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NCT00307515 · ClinicalTrials.gov registry record · Phase 3

Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery

A Phase 3 study of Blood Loss, Surgical, sponsored by Ethicon.

Completed
Registry status
Phase 3
Development phase
135
Enrollment target
16
Study locations

NCT00307515: Completed Phase 3 study of Blood Loss, Surgical, sponsored by Ethicon.

NCT00307515 is a Phase 3 study of Blood Loss, Surgical that has completed, run by Ethicon. The registered enrollment target is 135 participants, above the 114-participant average among 6 other Blood Loss, Surgical trials with a reported enrollment target (18% higher). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00307515, a Phase 3 study of Blood Loss, Surgical, has completed, sponsored by Ethicon.

COMPLETED
Registry status
Phase 3
Development phase
135 participants
Enrollment target
16
Study locations

Study Summary

A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.

Conditions Studied

Interventions

  • DRUG Fibrin Sealant 2 (FS2)
  • DEVICE Oxidized Regenerated Cellulose (Surgicel)

Study Locations (16)

Pennsylvania

  • Lehigh Valley Hospital - Allentown
  • Children's Hospital of Pittsburgh - Pittsburgh
  • Lankenau Hospital - Wynnewood

Florida

  • Jacksonville Center for Clinical Research - Jacksonville
  • Miami Research Associates - Miami

New York

  • Mt. Sinai Hospital - New York
  • GYN Oncology Associates - Syracuse

Texas

  • MD Anderson Cancer Center - Houston
  • The Methodist Hospital - Houston

California

  • Children's Hospital of Los Angeles - Los Angeles

Georgia

  • Medical College of Georgia - Augusta

Iowa

  • The Iowa Clinic - Des Moines

Maryland

  • St. Agnes Healthcare, Inc. - Baltimore

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2006-02
Est. Completion 2006-12
Phase Phase 3
Ethicon

38 total trials

What the finished NCT00307515 record still lists

NCT00307515 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 6 other Blood Loss, Surgical trials with a reported enrollment target (18% higher).

The record links to 1 condition, with Blood Loss, Surgical appearing as the primary indexed condition, and to 2 interventions - of which Fibrin Sealant 2 (FS2) is the first listed.

NCT00307515 lists 16 locations in 11 states (Pennsylvania, Florida, New York).

Frequently Asked Questions

What is clinical trial NCT00307515 about?

NCT00307515 is a clinical study titled "Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery". A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.

What is the current status of trial NCT00307515?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2006-02. Estimated completion is 2006-12.

What conditions does trial NCT00307515 study?

This clinical trial studies the following conditions: Blood Loss, Surgical.

What interventions are being tested in trial NCT00307515?

The interventions under investigation include: Fibrin Sealant 2 (FS2) (DRUG), Oxidized Regenerated Cellulose (Surgicel) (DEVICE).

Who is sponsoring clinical trial NCT00307515?

This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00307515 being conducted?

This trial has 16 study locations across California, Florida, Georgia, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00307515, the US trial registry maintained by the National Library of Medicine. NCT00307515 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.