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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
Recruitment status was: Not yet recruiting
Sponsor:
Hadassah Medical Organization
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01464528
First received: August 15, 2011
Last updated: November 2, 2011
Last verified: July 2011
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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 Blind (Participant) Primary Purpose: Prevention |
| Official Title: | Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery |
Resource links provided by NLM:
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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01464528
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | August 15, 2011 |
| Last Updated: | November 2, 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 |
ClinicalTrials.gov processed this record on July 19, 2017