Evaluation of Adhexil Safety and Efficacy in Prevention a... | NCT00865488

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

NCT00865488

Sponsor

OMRIX Biopharmaceuticals

Status

Suspended

Last Update Posted

Dec 23, 2009Estimated

Enrollment

80Estimated

Phase

Phase 3

Conditions

Ovarian Cysts
Endometriosis
Adhesions

Interventions

ADHEXIL

Countries

United States
Germany
Mexico
Russia
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Feb 2010Estimated

Completion Date

Apr 2010Estimated

First Submitted Date

Mar 18, 2009

First Submission Date that Met QC Criteria

Mar 18, 2009

First Posted Date

Mar 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2009

Last Update Posted Date

Dec 23, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ADHEXIL	Biological	Adhesions prevention	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adhesions will be assessed according to incidence, extent and severity.		8 weeks post surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eran Kurman, B.med.Sc, MBA	OMRIX Biopharmaceuticals	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Richmond	Virginia		United States

Condition Browse Module

MeSH Terms

ID	Term
D010048	Ovarian Cysts
D004715	Endometriosis
D000267	Tissue Adhesions

Ancestor Terms

ID	Term
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided