Safety Study of Use of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tissue Adhesions | Drug: Hyaluronan | Early Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Hyaluronan
Use of hyaluronic acid gel
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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 |
- Patient satisfaction following gel application [ Time Frame: 2 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Contact: ariel revel, md | 97226777111 ext 76389 | arielr2@hadassah.org.il | |
Contact: hanna Bechori | 97226777111 ext 76389 | hannab@hadassah.org.il |
Principal Investigator: | Ariel Revel, MD | Hadassah |
Responsible Party: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT01464528 |
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 |
hysteroscopy postoperative complications adhesions hyaluronic gel prevention |
Tissue Adhesions Cicatrix Fibrosis Pathologic Processes Hyaluronic Acid |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |