NCT00865488

Brief 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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

Geographic Reach
5 countries

5 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

9 months

First QC Date

March 18, 2009

Last Update Submit

December 20, 2009

Conditions

Ovarian CystsEndometriosisAdhesions

Outcome Measures

Primary Outcomes (1)

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

    8 weeks post surgery

Study Arms (2)

1

NO INTERVENTION

patients who will be treated in accordance with standard of care

2

EXPERIMENTAL

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

Biological: ADHEXIL

Interventions

ADHEXILBIOLOGICAL

Adhesions prevention

2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Duisburg, Germany

Location

Unknown Facility

Mexico City, Mexico

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Valencia, Spain

Location

MeSH Terms

Conditions

Ovarian CystsEndometriosisTissue Adhesions

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eran Kurman, B.med.Sc, MBA

    OMRIX Biopharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2010

Study Completion

April 1, 2010

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

ES(1)RU(1)US(1)ME(1)DE(1)