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[Prova di un dispositivo non approvato o autorizzato dalla FDA statunitense]

2 novembre 2026 aggiornato da: Ethicon, Inc.

The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

108

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Olanda
      • Nijmegen, Olanda, 6500HB
        • UMC Radboud
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90033
        • Keck Hospital of USC
    • Missouri
      • St Louis, Missouri, Stati Uniti, 63110
        • Washington University Barnes Jewish Hospital
    • New Jersey
      • Pennington, New Jersey, Stati Uniti, 08534
        • Capital Health Medical Center - Hopewell
    • New York
      • New York, New York, Stati Uniti, 10065
        • New York Presbyterian - Weill Cornell Medical Ctr
    • Texas
      • Tyler, Texas, Stati Uniti, 75701
        • UT Health East Texas EMS Air 1
    • Utah
      • Murray, Utah, Stati Uniti, 84107
        • Intermountain Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

22 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Pre-operative

  • Participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure
  • Participant is willing and able to give written informed consent for the clinical investigation participation

Intra-operative

  • Participant in whom the Investigator can identify and visualize a target bleeding site for which any applicable conventional means for hemostasis (e.g., suture, ligature, or cautery) are ineffective or impractical
  • Target Bleeding Site is identified to originate from soft tissue, defined as organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle
  • The choice is made to use a hemostatic agent to stop the bleeding, and there is the ability to apply pressure on the surface of the hemostatic agent to achieve hemostasis
  • Participant has a Target Bleeding Site with a SBSS score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities)

Exclusion Criteria:

Pre-operative

  • Participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL Original application
  • Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid
  • Participant has an active or suspected infection at the bleeding site
  • Participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period

Intra-operative

  • Target bleeding site is identified to originate from parenchymal organ tissue, cardiovascular (anastomotic or cardiovascular repair sites) tissue, or is in proximity to a foramina in bone, or areas of bony confine
  • Target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ETHIZIA

ETHIZIA will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed up for 28 days after surgery.
Dispositivo: ETHIZIA

ETHIZIA patch will be applied to bleeding site intraoperatively.
Comparatore attivo: SURGICEL Original

SURGICEL Original will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed-up for 28 days after surgery.
Dispositivo: SURGICEL Original

SURGICEL Original will be applied to bleeding site intraoperatively.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at The Target Bleeding Site
Lasso di tempo: Intraoperative (up to 10 minutes)

Cases achieving hemostasis at 3 minutes following product application & with no rebleeding up to 10 minutes following application at the target bleeding site (first bleeding site treated) will be determined by Surface Bleeding Severity Scale (SBSS). SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatening). A grade of 0 (None/Dry) on the SBSS is considered as achieving hemostasis.
Intraoperative (up to 10 minutes)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Hemostasis at Target Bleeding Site
Lasso di tempo: Intraoperative (up to 10 minutes)

Time to achieve hemostasis for target bleeding site up to 10 minutes will be evaluated and presented using Kaplan-Meier estimated distribution.
Intraoperative (up to 10 minutes)
Percentage of Bleeding Sites Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at All Treated Bleeding Sites
Lasso di tempo: Intraoperative (up to 10 minutes)

Percentage of bleeding sites achieving hemostasis at 3 minutes following product application & with no rebleeding up to 10 minutes following application at all bleeding sites (additional bleeding sites treated including target bleeding site) will be determined by SBSS. SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatening).
Intraoperative (up to 10 minutes)
Time to Hemostasis for All Treated Bleeding Sites
Lasso di tempo: Intraoperative (up to 10 minutes)

Time to achieve hemostasis for all treated bleeding sites for up to 10 minutes will be evaluated.
Intraoperative (up to 10 minutes)
Median Time to Hemostasis at Target Bleeding Site
Lasso di tempo: Intraoperative

Median time to hemostasis at target bleeding site will be reported.
Intraoperative
Median Time to Hemostasis for All Treated Bleeding Sites
Lasso di tempo: Intraoperative

Median time to hemostasis for all treated bleeding sites will be reported for both groups.
Intraoperative
Treatment Failure for Target Bleeding Site Treated and for All Treated Bleeding Sites
Lasso di tempo: Intraoperative (up to 10 minutes)

Treatment failure is defined as no hemostasis at 10 minutes or received rescue therapy prior to 10 minutes from the application of the study product.
Intraoperative (up to 10 minutes)
Sustained Hemostasis at All Treated Bleeding Sites
Lasso di tempo: Intraoperative

Sustained hemostasis at all treated bleeding sites will be reported. Sustained hemostasis is defined as achieving hemostasis at 3 minutes with no rebleeding up to Day 28.
Intraoperative
Proportion of Bleeding Sites with Rebleeding After 10 Minutes
Lasso di tempo: Intraoperative

Proportion of bleeding sites with rebleeding after 10 minutes and prior to initiation of final fascia closure will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.
Intraoperative
Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original
Lasso di tempo: At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds

Percentage of bleeding sites achieving hemostasis with ETHIZIA or SURGICEL Original will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.
At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds
Proportion of Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis
Lasso di tempo: Intraoperative

Proportion of bleeding sites requiring more than one application of randomized product in order to achieve hemostasis will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.
Intraoperative
Proportion of Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis
Lasso di tempo: Intraoperative

Proportion of bleeding sites that require a second surgical maneuver (for example, adjunct product, electrocautery, etcetera) as a rescue therapy to achieve hemostasis following treatment will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.
Intraoperative

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ethicon, Inc.

Investigatori

  • Direttore dello studio: Ethicon Inc. Clinical Trial, Ethicon, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 aprile 2025

Completamento primario (Effettivo)

3 settembre 2026

Completamento dello studio (Effettivo)

7 ottobre 2026

Date di iscrizione allo studio

Primo inviato

28 ottobre 2024

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2024

Primo Inserito (Effettivo)

30 ottobre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • BIO202401
  • BIO202401 (Altro identificatore: Ethicon,Inc)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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