Safety Study of Use of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery

November 2, 2011 updated by: Hadassah Medical Organization

Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery

Operations in the uterus are currently possible using a hysteroscope. One serious though rare complication of such procedures is the development of intra-uterine adhesions. There currently are no methods to prevent this. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Operations in the uterus are currently possible using a hysteroscopic approach. Intrauterine procedures include; polypectomy, myomectomy, removal of lost IUD,removal of a septum and more. One serious though rare complication of operative hysteroscopy is the development of intra-uterine adhesions. Such adhesions, also known as asherman's syndrome, can cause serious consequences such as infertility and miscarriage. The hypothesis is that the removal of the endometrium and the exposure of ra uterine wall to each other can cause attachment and adhesions. the treatment is to mechanically break the adhesion. recurrence is however common. There currently are no methods to prevent adhesions following curettage or hysteroscopy. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery. At a later research, the efficacy of barrier gel will be measures.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age 18 year old and over
  • need of hysteroscopic surgery

Exclusion Criteria:

  • preoperative fever or infection
  • malignancy
  • previous PID
  • contraindications for anesthesia
  • pregnancy
  • under 18 year old
  • not able to read and/or understand informed consent
  • taking any medicine other than oral contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Active Comparator: Hyaluronan
Use of hyaluronic acid gel
Drug: Hyaluronan
single use of 10 mL of the hyalobarrier gel intrauterine immediately following hysteroscopic surgery
Other Names:
  • hyaluronic acid, alcohol and carboxil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction following gel application
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Ariel Revel, MD, Hadassah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

November 3, 2011

Last Update Submitted That Met QC Criteria

November 2, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYALOBARRIER- HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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