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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2011 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01464528

First Posted: November 3, 2011

Last Update Posted: November 3, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Hadassah Medical Organization

Purpose

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.

Condition	Intervention	Phase
Tissue Adhesions	Drug: Hyaluronan	Early Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention
Official Title:	Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Adhesions

Drug Information available for: Hyaluronic Acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Patient satisfaction following gel application [ Time Frame: 2 months ]


Estimated Enrollment:	10
Study Start Date:	November 2011
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: hyaluronic acid, alcohol and carboxil
No Intervention: control

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.

Eligibility

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464528

Contacts


Contact: ariel revel, md	97226777111 ext 76389	arielr2@hadassah.org.il
Contact: hanna Bechori	97226777111 ext 76389	hannab@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

Investigators


Principal Investigator:	Ariel Revel, MD	Hadassah

More Information


Responsible Party:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT01464528 History of Changes
Other Study ID Numbers:	HYALOBARRIER- HMO-CTIL
First Submitted:	August 15, 2011
First Posted:	November 3, 2011
Last Update Posted:	November 3, 2011
Last Verified:	July 2011

Keywords provided by Hadassah Medical Organization:


hysteroscopy postoperative complications adhesions hyaluronic gel prevention

Additional relevant MeSH terms:


Tissue Adhesions Cicatrix Fibrosis Pathologic Processes Hyaluronic Acid	Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents

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