search
Back to results

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

Primary Purpose

Tissue Adhesions

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Hyaluronan
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tissue Adhesions focused on measuring hysteroscopy, postoperative complications, adhesions, hyaluronic gel, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Hyaluronan

    control

    Arm Description

    Use of hyaluronic acid gel

    Outcomes

    Primary Outcome Measures

    Patient satisfaction following gel application

    Secondary Outcome Measures

    Full Information

    First Posted
    August 15, 2011
    Last Updated
    November 2, 2011
    Sponsor
    Hadassah Medical Organization
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01464528
    Brief Title
    Safety Study of Use of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery
    Official Title
    Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    March 2012 (Anticipated)
    Study Completion Date
    May 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tissue Adhesions
    Keywords
    hysteroscopy, postoperative complications, adhesions, hyaluronic gel, prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hyaluronan
    Arm Type
    Active Comparator
    Arm Description
    Use of hyaluronic acid gel
    Arm Title
    control
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronan
    Other Intervention Name(s)
    hyaluronic acid, alcohol and carboxil
    Intervention Description
    single use of 10 mL of the hyalobarrier gel intrauterine immediately following hysteroscopic surgery
    Primary Outcome Measure Information:
    Title
    Patient satisfaction following gel application
    Time Frame
    2 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ariel revel, md
    Phone
    97226777111
    Ext
    76389
    Email
    arielr2@hadassah.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    hanna Bechori
    Phone
    97226777111
    Ext
    76389
    Email
    hannab@hadassah.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ariel Revel, MD
    Organizational Affiliation
    Hadassah
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs