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

This study is not yet open for participant recruitment.

Verified July 2012 by Carmel Medical Center

Sponsor:

Information provided by (Responsible Party):

Arie Lissak, MD, Carmel Medical Center

ClinicalTrials.gov Identifier:

NCT01637974

First received: July 9, 2012

Last updated: July 10, 2012

Last verified: July 2012

History of Changes

Purpose

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

Condition	Intervention
Asherman Syndrome Endometrial Polyp Uterine Myoma	Drug: INTERCOAT administration

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention
Official Title:	Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Adhesions

U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:

Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	August 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: with INTERCOAT injection of intercoat into the euterine cavity at the end of hysteroscopy	Drug: INTERCOAT administration Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery Other Name: INTERCOAT
No Intervention: without INTERCOAT	Drug: INTERCOAT administration Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery Other Name: INTERCOAT

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637974

Contacts

Contact: Moran PAZ, M.D.	972-4-8250637	MORANPA@CLALIT.GOV.IL
Contact: ARIE LISSAK, M.D.	972-4-8250345	LISSAK_ARIE@CLALIT.ORG.IL

Locations

Israel
Carmel Medical Center	Not yet recruiting
Haifa, Israel
Contact: Moran Paz, MD 972-4-8250637 MORANPA@CLALIT.ORG.IL
Contact: arie Lissak, MD 972-4-8250345 arie_lissak@clalit.org.il

Sponsors and Collaborators

Carmel Medical Center

More Information

No publications provided

Responsible Party:	Arie Lissak, MD, M.D., Carmel Medical Center
ClinicalTrials.gov Identifier:	NCT01637974 History of Changes
Other Study ID Numbers:	CMC-11-0050-CTIL
Study First Received:	July 9, 2012
Last Updated:	July 10, 2012
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Myoma
Leiomyoma
Myofibroma
Adenoma
Uterine Neoplasms
Polyps
Gynatresia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Neoplasms, Glandular and Epithelial
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 17, 2013

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