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Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial Carcinoma

1. juni 2026 opdateret af: University of Michigan Rogel Cancer Center

A Prospective Clinical Assessment of Office-Based Ureteroscopy for Upper Tract Urothelial Carcinoma Utilizing a 6.3 French Single Use Digital Flexible Ureteroscope

This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma. Ureteroscopy is traditionally performed in an operating room under general anesthesia. In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind. Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis. Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Rogel Cancer Center
        • Ledende efterforsker:
          • Khurshid Ghani, MD
        • Kontakt:

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

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥ 18 year. Both sexes are included to reflect the patient population with upper tract urothelial carcinoma (UTUC) already being followed at the University of Michigan and allow exploration of potential differences in tolerability of awake ureteroscopy based on sex
  • History of endoscopically managed UTUC at any time, or a suspected diagnosis of UTUC based on pre-procedure imaging, and is already planned for office-based ureteroscopic assessment
  • Ability and willingness to complete and adhere to survey questions and responses throughout study duration

Exclusion Criteria:

  • Known ureteral strictures
  • Active urinary tract infection
  • Need for general anesthesia due to patient or procedural factors
  • History of inability to tolerate ureteroscopy under local anesthetic
  • Anticipated need for laser ablation during the surveillance procedure
  • Pregnancy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diagnostic (in office ureteroscopy)
Patients receive lidocaine jelly intraurethrally for local anesthesia. Patients then undergo ureteroscopy using the 6.3 Fr single use digital ureteroscope. Per standard of care practice, patients receive pain medication PO on an as needed basis prior to and immediately after the procedure.
Andet: Undersøgelsesadministration
Hjælpestudier
Andet: Gennemgang af elektronisk sygejournal
Hjælpestudier
Medicin: Analgesic Agent
Given PO
Andre navne:
  • Analgetika
  • smertestillende
  • Analgesic Drugs
  • Anodynes
  • Antinociceptive Agents
  • Pain-relief Medication
Medicin: Lidocaine Topical
Given intraurethrally
Enhed: Medical Device Usage and Evaluation
Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope
Procedure: Ureteroscopy
Undergo ureteroscopy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Success rate
Tidsramme: On day of procedure
Defined as the ability to successfully perform and complete upper and lower tract surveillance with the 6.3 French ureteroscope in an office setting. A study-wide successful outcome will be defined as a success rate of 70%. The success rate will be reported as the count and proportion of participants with a successful outcome out of the number of enrolled participants. The corresponding 95% binomial Clopper-Pearson confidence interval will be reported.
On day of procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain
Tidsramme: From baseline up to 7-10 days post procedure
Assessed by intra- and peri-procedure patient reported outcomes with the visual analogue scale pain score, as well as the Patient-Reported Outcomes Measurement Information System Pain Interference and Intensity score. Will be summarized and displayed graphically with means, standard deviations and/or quartiles.
From baseline up to 7-10 days post procedure
Satisfaction
Tidsramme: At 7-10 days post procedure
Assessed by the International Consultation on Incontinence-Satisfaction. Will be summarized and displayed graphically with means, standard deviations and/or quartiles.
At 7-10 days post procedure
Unplanned healthcare use
Tidsramme: From baseline up to 30 days post procedure
Will measure unplanned healthcare utilization including electronic messages, phone calls, lab and imaging tests, emergency department visits, hospitalizations, and secondary interventions. These will be reported as counts of events and counts of participants with corresponding proportions of enrolled participants.
From baseline up to 30 days post procedure

Samarbejdspartnere og efterforskere

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

Sponsor

University of Michigan Rogel Cancer Center

Samarbejdspartnere

Shenzhen HugeMed Medical Technical Development

Efterforskere

  • Ledende efterforsker: Khurshid Ghani, MD, University of Michigan Rogel Cancer Center

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 (Anslået)

18. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UMCC 2025.155
  • NCI-2026-03864 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • HUM00284243

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Nyrebækken og Ureter Urothelial Carcinoma

Kliniske forsøg med Undersøgelsesadministration

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner