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SuspendedNCT00865488Updated Dec 23, 2009

Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

A Phase 3 interventional study of ADHEXIL in Ovarian Cysts, Endometriosis and Adhesions, sponsored by OMRIX Biopharmaceuticals. Suspended at 5 sites in 5 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-12-23.

Sponsored by OMRIX Biopharmaceuticals (part of Johnson & Johnson) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Read the detailed description

Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.

02

Conditions studied

  • Ovarian Cysts
  • Endometriosis
  • Adhesions
03

In context

Ovarian Cysts

76 studies on the registry are indexed under Ovarian Cysts; 15 are open to participants now.

This study's planned enrollment of 80 is above the median of 71 across 50 interventional studies indexed under Ovarian Cysts.

Browse Ovarian Cysts studies →

Lead sponsor

OMRIX Biopharmaceuticals is the lead sponsor of 3 studies on the registry; none are open to participants now.

First submitted after OMRIX Biopharmaceuticals became part of Johnson & Johnson.

Browse OMRIX Biopharmaceuticals studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients aged 18-45 years at screening.
  • Patients undergoing elective laparoscopic surgery involving at least one adnexa.

Exclusion criteria

Exclusion Criteria:

  • Pregnant (including ectopic pregnancy) or breastfeeding patient.
  • Patients with a documented diagnosis of cancer.
  • Patients with a lymphatic, hematologic or coagulation disorder.
  • Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™.
  • Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
  • Patients who have participated in another clinical study within 30 days of enrolment.
  • Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • No intervention
    1

    patients who will be treated in accordance with standard of care

  • Experimental
    2

    patients for which Adhexil will be applied to prevent/reduce adhesions

    Biological: ADHEXIL

Interventions

  • BiologicalADHEXIL

    Adhesions prevention

06

What researchers measure

Primary outcomes

  1. Adhesions will be assessed according to incidence, extent and severity.

    Time frame: 8 weeks post surgery

07

Study locations

5 sites
  • Richmond, Virginia, United States
  • Duisburg, Germany
  • Mexico City, Mexico
  • Moscow, Russia
  • Valencia, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00865488
Lead sponsor
OMRIX Biopharmaceuticals
First posted
Mar 19, 2009
Start date
May 2009
Primary completion
Feb 2010 (estimated)
Completion
Apr 2010 (estimated)
Last update
Dec 23, 2009

Study contacts

Eran Kurman, B.med.Sc, MBA
study chair · OMRIX Biopharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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