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

NCT ID: NCT01464528

Last Updated: 2011-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Tissue Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Hyaluronan

Use of hyaluronic acid gel

Group Type ACTIVE_COMPARATOR

Hyaluronan

Intervention Type DRUG

single use of 10 mL of the hyalobarrier gel intrauterine immediately following hysteroscopic surgery

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyaluronan

single use of 10 mL of the hyalobarrier gel intrauterine immediately following hysteroscopic surgery

Intervention Type DRUG

Other Intervention Names

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hyaluronic acid, alcohol and carboxil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ariel Revel, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah

Central Contacts

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ariel revel, md

Role: CONTACT

[email protected]
97226777111 ext. 76389

hanna Bechori

Role: CONTACT

[email protected]
97226777111 ext. 76389

Other Identifiers

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HYALOBARRIER- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id