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Foam Sclerotherapy With or Without Transdermal Laser for Reticular Veins and Telangiectasias

5. november 2026 opdateret af: Cecília Salazar Ulacia, University of Sao Paulo

Comparison Between Isolated Foam Sclerotherapy and Foam Sclerotherapy Combined With Transdermal Laser for the Treatment of Reticular Veins and Telangiectasias: A Prospective Randomized Clinical Trial

This prospective, randomized, controlled, intraindividual split-leg clinical trial will compare isolated polidocanol foam sclerotherapy with the Cryo-Laser After Foam (CLaF) technique for the treatment of reticular veins and telangiectasias of the lower limbs. The study will include 70 women aged 18 to 60 years with bilateral CEAP C1 telangiectasias and/or reticular veins. Each participant will receive CLaF in one lower limb and isolated foam sclerotherapy in the contralateral limb, with treatment laterality determined by randomization. The CLaF technique consists of polidocanol foam sclerotherapy followed immediately by transdermal 1064-nm Nd:YAG laser under continuous cold-air cooling. The study will evaluate vascular clearance, residual vascular area, hyperpigmentation, retained thrombi and need for drainage, pain, adverse events, aesthetic improvement, patient satisfaction, and quality of life during follow-up through 180 days.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Telangiectasias and reticular veins are common manifestations of chronic venous disease classified as CEAP C1. Although they are frequently considered primarily aesthetic findings, they may be associated with local symptoms and may negatively affect quality of life and body perception.

Foam sclerotherapy with polidocanol is widely used for the treatment of reticular veins and telangiectasias. However, post-treatment hyperpigmentation, retained thrombi, telangiectatic matting, superficial phlebitis, prolonged ecchymosis, and the need for drainage may occur.

The Cryo-Laser After Foam (CLaF) technique combines polidocanol foam sclerotherapy with subsequent transdermal laser treatment under continuous cold-air cooling. In this technique, polidocanol foam is injected first, followed immediately by application of a long-pulsed 1064-nm Nd:YAG laser over the treated vessels while continuous cold-air cooling is applied to the skin. Foam sclerotherapy remains the primary therapeutic component of the procedure. The proposed rationale is that combining chemical and photothermal mechanisms may enhance vascular occlusion and potentially reduce residual intravascular blood, retained thrombi, and hyperpigmentation, while cold-air cooling provides epidermal protection and improves patient comfort during laser application.

This is a prospective, randomized, controlled, intraindividual, split-leg, assessor-blinded, single-center clinical trial. Seventy women aged 18 to 60 years with bilateral relatively symmetrical CEAP C1 telangiectasias and/or reticular veins will be included. Randomization will determine which lower limb receives CLaF, while the contralateral limb receives isolated polidocanol foam sclerotherapy. Each participant will therefore serve as her own control.

Polidocanol 0.5% foam will constitute the primary sclerosing treatment in both lower limbs. For very small telangiectasias, liquid polidocanol 0.25% may be used as a complementary intravascular microinjection according to the study protocol. The same sclerotherapy criteria will be applied bilaterally.

In the CLaF-treated limb, the Nd:YAG laser will be applied immediately after sclerotherapy under continuous cold-air cooling. For telangiectasias smaller than 1 mm, the laser parameters will be a 2-mm spot size, fluence of 200 J/cm², and pulse duration of 15 ms. For reticular veins measuring 1-3 mm, a 6-mm spot size, fluence of 70 J/cm², and pulse duration of 30 ms will be used. A maximum of 150 laser shots per standardized treatment area is planned.

Treatment will be performed in standardized bilateral 20 × 15 cm areas of the lateral thigh-leg region. Standardized digital photographs and semiautomated image analysis will be used to assess residual vascular area and vascular clearance. Skin pigmentation will also be evaluated clinically, photographically, and instrumentally using a Mexameter®. Additional outcomes will include the Global Aesthetic Improvement Scale (GAIS), pain, retained thrombi, need for drainage, telangiectatic matting, superficial phlebitis, other adverse events, patient satisfaction, and quality of life. Follow-up assessments are planned through 180 days.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
70

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Brasilien
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasilien, 14040-900
        • Rekruttering
        • Clínica Civil - FAEPA USP
        • Kontakt:
        • Ledende efterforsker:
          • Cecília S Ulacia, MD
        • Underforsker:
          • Mauricio Serra Ribeiro, PHD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Female participants aged 18 to 60 years.
  • Fitzpatrick skin phototype I, II, or III.
  • CEAP clinical class C1.
  • Bilateral relatively symmetrical presence of telangiectasias and reticular veins on the lateral thigh.
  • Presence of telangiectasias and reticular veins measuring 0.1 to 3 mm in diameter.
  • Body mass index (BMI) ≤ 30 kg/m²
  • Willingness to participate in the complete study follow-up and provision of written informed consent.

Exclusion Criteria:

  • Saphenous or perforator venous reflux.
  • Varicose veins greater than 3 mm in diameter (CEAP C2-C6).
  • Fitzpatrick skin phototype IV, V, or VI.
  • Recent venous thrombosis or known thrombophilia.
  • Use of anticoagulant therapy.
  • Pregnancy or breastfeeding.
  • Known allergy to polidocanol.
  • Peripheral arterial disease with ankle-brachial index (ABI) < 0.8.
  • Diabetes mellitus.
  • Local dermatitis in the treatment area.
  • Previous venous treatment within the last 6 months.
  • Failure to attend the treatment session or scheduled follow-up visits.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Aktiv komparator: Isolated Foam Sclerotherapy

The lower limb allocated to the control treatment will receive isolated sclerotherapy with 0.5% polidocanol foam within the standardized treatment area. The contralateral lower limb of the same participant will receive Laser After Foam (LAAF). Treatment laterality will be determined by randomization
Medicin: Polidocanol foam sclerotherapy

Polidocanol 0.5% foam will be prepared immediately before application using the Tessari technique by mixing 1 mL of 0.5% polidocanol with 4 mL of room air in a 1:4 ratio, using two syringes connected by a three-way stopcock and approximately 20 passages for homogenization. A maximum foam volume of 2 mL per treated area will be used. Intravascul ar microinjections will be performed with a fine needle, preferably 25G, in fractionated volumes and at a controlled rate. For very small telangiectasias, 0.25% liquid polidocanol may be used as a complementary intravascular microinjection. After treatment, standardized light local compression will be maintained for approximately 24 hours.

Andre navne:
  • Polidocanol 0.5% Foam
Eksperimentel: Cryo-Laser After Foam (CLaF)

The lower limb allocated to CLaF will receive 0.5% polidocanol foam sclerotherapy followed immediately by long-pulsed transdermal 1064-nm Nd:YAG laser treatment under continuous cold-air cooling. For very small telangiectasias, 0.25% liquid polidocanol may be used as a complementary intravascular microinjection according to the study protocol. The contralateral lower limb of the same participant will receive isolated polidocanol foam sclerotherapy. Treatment laterality will be determined by randomization.
Medicin: Polidocanol foam sclerotherapy

Polidocanol 0.5% foam will be prepared immediately before application using the Tessari technique by mixing 1 mL of 0.5% polidocanol with 4 mL of room air in a 1:4 ratio, using two syringes connected by a three-way stopcock and approximately 20 passages for homogenization. A maximum foam volume of 2 mL per treated area will be used. Intravascul ar microinjections will be performed with a fine needle, preferably 25G, in fractionated volumes and at a controlled rate. For very small telangiectasias, 0.25% liquid polidocanol may be used as a complementary intravascular microinjection. After treatment, standardized light local compression will be maintained for approximately 24 hours.

Andre navne:
  • Polidocanol 0.5% Foam
Enhed: Transdermal 1064 nm Nd:YAG Laser

Immediately after polidocanol sclerotherapy, a long-pulsed transdermal 1064-nm Nd:YAG laser will be applied over the treated vessels under continuous cold-air cooling at approximately -20°C, characterizing the Cryo-Laser After Foam (CLaF) technique. Approximately 10% spot overlap may be used, with up to two passes over the target vessel. A maximum of 150 laser shots per standardized 20 × 15 cm treatment area is planned, unless earlier interruption is required for safety. For telangiectasias smaller than 1 mm, the laser parameters will be a 2-mm spot size, fluence of 200 J/cm², and pulse duration of 15 ms. For reticular veins measuring 1-3 mm, the parameters will be a 6-mm spot size, fluence of 70 J/cm², and pulse duration of 30 ms. Continuous cold-air cooling will be maintained throughout laser application for epidermal protection and patient comfort.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change in Residual Vascular Area From Baseline to Days 60, 90 and 180
Tidsramme: Baseline and Day 60,90 and 180

Residual vascular area will be quantified from standardized digital photographs using semiautomated image analysis, preferably with ImageJ/Fiji, within the standardized 20 × 15 cm treatment area. Change in residual vascular area will be expressed as a percentage relative to baseline at each follow-up time point. The paired intraindividual comparison will be performed between the area treated with CLaF and the contralateral area treated with isolated foam sclerotherapy.
Baseline and Day 60,90 and 180

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vascular Clearance by Blinded Photographic Assessment
Tidsramme: Day 60, Day 90, and Day 180

Standardized digital photographs will be independently assessed by two blinded outcome assessors. Vascular clearance will be evaluated by comparing follow-up images with baseline images within the standardized treatment area. In case of clinically relevant disagreement, a third blinded assessor will perform adjudication.
Day 60, Day 90, and Day 180
Global Aesthetic Improvement Scale (GAIS) Score
Tidsramme: Day 60, Day 90, and Day 180

Global aesthetic improvement will be assessed using the protocol-adapted Global Aesthetic Improvement Scale (GAIS), ranging from -1 to 3. A score of -1 indicates worsening, 0 indicates no change, 1 indicates improvement, 2 indicates marked improvement, and 3 indicates very marked improvement or excellent aesthetic result
Day 60, Day 90, and Day 180
Incidence and Intensity of Hyperpigmentation
Tidsramme: Day 60, Day 90, and Day 180

Post-treatment hyperpigmentation will be assessed clinically and photographically in the treated area. Hyperpigmentation will be recorded as present or absent and its clinical intensity will be documented. Results will be compared between the ClaF-treated limb and the contralateral limb treated with isolated foam sclerotherapy.
Day 60, Day 90, and Day 180
Change in Melanin Index Measured With Mexameter
Tidsramme: Baseline, Day 60, Day 90, and Day 180

Skin pigmentation will be objectively measured using the Mexameter. Standardized measurement points will include the area of greatest pigmentation, when present, and adjacent untreated control skin. Each point will be measured three consecutive times and the arithmetic mean will be used. Change in melanin index will be compared with baseline and adjacent untreated skin.
Baseline, Day 60, Day 90, and Day 180
Incidence of Retained Thrombus and Need for Drainage
Tidsramme: Day 21

Retained thrombus will be assessed clinically and defined as palpable or visible thrombotic material within the treated venous segment. The presence or absence, approximate size, associated pain, and need for drainage will be recorded.

The need for drainage of retained thrombus will be recorded. Drainage may be indicated in the presence of a dark superficial thrombus, painful palpable cord, intravascular nodule, or local pain equal to or greater than 4 on the pain scale, according to the clinical assessor. When performed, the treated limb, date, approximate drained volume, and complications will be recorded.
Day 21
Procedure-Related Pain
Tidsramme: Day 0

Pain will be assessed using a numerical rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain will be recorded for the sclerotherapy stage, the transdermal laser stage when applicable, and the overall procedure
Day 0
Incidence of Telangiectatic Matting, Superficial Phlebitis, Persistent Ecchymosis, Skin Necrosis or Wound, Thromboembolic Events
Tidsramme: Day 60, Day 90 and Day 180

Telangiectatic matting will be defined as the appearance of new fine network-like telangiectasias within the treated area. Presence or absence and extension of matting will be recorded and compared between treatment techniques.

Superficial phlebitis will be assessed clinically based on pain, erythema, and induration along the treated venous segment. Severity and any treatment instituted will be recorded.

Persistent ecchymosis will be assessed clinically and defined as ecchymosis persisting beyond the expected post-treatment period or considered clinically relevant during follow-up. Its extent and resolution will be documented.

Skin necrosis or wound will be defined as loss of skin integrity within the treated area. When present, lesion dimensions, treatment instituted, and clinical evolution will be recorded.

Suspected thromboembolic events, including deep vein thrombosis or pulmonary embolism, will be investigated and recorded. Diagnostic confirmation, clinical management, and notifi
Day 60, Day 90 and Day 180
Change in Chronic Venous Insufficiency Questionnaire-14 (CIVIQ-14) Global Index Score From Baseline to Days 90 and 180
Tidsramme: Baseline, Day 90, and Day 180

Quality of life related to chronic venous disease will be assessed using the Chronic Venous Insufficiency Questionnaire-14 (CIVIQ-14). The questionnaire contains 14 items. Scores will be calculated according to the prespecified scoring method and expressed on a 0 to 100 Global Index Score, with higher scores indicating better quality of life. Change from baseline will be assessed at Day 90 and Day 180. This is a participant-level outcome and will not be attributed separately to either lower limb or intervention.
Baseline, Day 90, and Day 180
Change in VEINES-QOL Score From Baseline to Days 90 and 180
Tidsramme: Baseline, Day 90, and Day 180

Venous disease-specific quality of life will be assessed using the Brazilian Portuguese version of the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptoms questionnaire (VEINES-QOL/Sym). The VEINES-QOL score is derived from 25 items included in questions 1, 3, 4, 5, 6, 7, and 8; question 2 is descriptive and is not included in the score.

The score will be calculated using intrinsic scoring. After orienting item responses so that higher values indicate a better health status, each item response will be transformed using (i-1)/(k-1), where i is the response category and k is the number of response categories for that item. The mean of the available transformed items will then be multiplied by 100.

The VEINES-QOL score ranges from 0 to 100, with higher scores indicating better venous disease-specific quality of life. The score will not be calculated when more than 50% of the relevant items are missing. Change from baseline will be assessed at Day 90 and Day
Baseline, Day 90, and Day 180
Change in VEINES-Sym Score From Baseline to Days 90 and 180
Tidsramme: Baseline, Day 90, and Day 180

Venous symptoms will be assessed using the VEINES-Sym component of the Brazilian Portuguese version of the Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptoms questionnaire (VEINES-QOL/Sym). The VEINES-Sym score is derived from 10 items: the nine venous symptom items included in question 1 and the leg pain item included in question 7.

The score will be calculated using intrinsic scoring. After orienting item responses so that higher values indicate a better health status, each item response will be transformed using (i-1)/(k-1), where i is the response category and k is the number of response categories for that item. The mean of the available transformed items will then be multiplied by 100.

The VEINES-Sym score ranges from 0 to 100, with higher scores indicating fewer or less severe venous symptoms and a better symptom status. The score will not be calculated when more than 50% of the relevant items are missing. Change from baseline will be assessed at
Baseline, Day 90, and Day 180

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Treatment Preference
Tidsramme: Day 180

At the final follow-up visit, the participant's preference regarding the aesthetic result of the two treated lower limbs will be recorded
Day 180
Need for Retreatment of the Treated Area
Tidsramme: Day 180

The need for additional treatment of residual or recurrent reticular veins and telangiectasias within the standardized treated area will be assessed at the final follow-up visit
Day 180

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
University of Sao Paulo

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Cecília S Ulacia, MD, University of Sao Paulo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. september 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. februar 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. maj 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
20. august 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
26. august 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
28. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
5. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 99535826.1.0000.5440

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No individual participant data (IPD) sharing is planned under the current study protocol. Participant data will be kept confidential and identified only by an alphanumeric study code. Study results will be reported in aggregate form without identification of individual participants.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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