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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT01464528
Collaborator
(none)
10
Enrollment
2
Arms
6
Duration (Months)

Study Details

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
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
Anticipated 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 :
Nov 1, 2011
Anticipated Primary Completion Date :
Mar 1, 2012
Anticipated Study Completion Date :
May 1, 2012

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 Names:
  • hyaluronic acid, alcohol and carboxil

    		•
    No Intervention: control

    Outcome Measures

    Primary Outcome Measures

    1. Patient satisfaction following gel application [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

    • Principal Investigator: Ariel Revel, MD, Hadassah

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT01464528
    Other Study ID Numbers:
    • HYALOBARRIER- HMO-CTIL
    First Posted:
    Nov 3, 2011
    Last Update Posted:
    Nov 3, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by Hadassah Medical Organization
    hysteroscopy
    postoperative complications
    adhesions
    hyaluronic gel
    prevention
    Additional relevant MeSH terms:
    Tissue Adhesions
    Hyaluronic Acid

    Study Results

    No Results Posted as of Nov 3, 2011