Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery

NCT ID: NCT01637974

Last Updated: 2015-07-31

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

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-03-31

Brief Summary

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The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.

Detailed Description

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Conditions

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Asherman Syndrome Endometrial Polyp Uterine Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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with INTERCOAT

injection of intercoat into the euterine cavity at the end of hysteroscopy

Group Type EXPERIMENTAL

INTERCOAT administration

Intervention Type DRUG

Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery

without INTERCOAT

without INTERCOAT

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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INTERCOAT administration

Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery

Intervention Type DRUG

Other Intervention Names

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INTERCOAT

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 50 years
* Must be able to understand, read and sign consent form

Exclusion Criteria

* Signs of infection upon admission
* Ongoing pregnancy
* Carcinoma of the uterus or cervix
* Recurrent PID
* Women admitted for endometrial ablation
* Women that gave birth 6 weeks ago
* Women participating in another study
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Moran Paz

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Carmel Medical Center

Haifa, Haifa District, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Moran PAZ, M.D.

Role: CONTACT

972-4-8250637

Yuval Kaufman, M.D.

Role: CONTACT

972-4-8250345

Facility Contacts

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Moran Paz, MD

Role: primary

972-4-8250637

Yuval Kaufman, MD

Role: backup

972-4-8250345

Other Identifiers

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CMC-11-0050-CTIL

Identifier Type: -

Identifier Source: org_study_id

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