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

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.
ClinicalTrials.gov Identifier: NCT01464528
Recruitment Status : Unknown
Verified July 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : November 3, 2011
Last Update Posted : November 3, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Tissue Adhesions Drug: Hyaluronan Early Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : November 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Patient satisfaction following gel application [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: November 3, 2011    Key Record Dates
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