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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01637974
Recruitment Status : Unknown
Verified July 2015 by Moran Paz, Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : July 11, 2012
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Moran Paz, Carmel Medical Center

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

Condition or disease Intervention/treatment Phase
Asherman Syndrome Endometrial Polyp Uterine Myoma Drug: INTERCOAT administration Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : December 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
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
without INTERCOAT


Outcome Measures
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Primary Outcome Measures :
  1. Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

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): NCT01637974


Contacts
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Contact: Moran PAZ, M.D. 972-4-8250637 MORANPA@CLALIT.GOV.IL
Contact: Yuval Kaufman, M.D. 972-4-8250345 mdykaufman@clalit.org.il

Locations
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Israel
Carmel Medical Center Recruiting
Haifa, Israel
Contact: Moran Paz, MD    972-4-8250637    MORANPA@CLALIT.ORG.IL   
Contact: Yuval Kaufman, MD    972-4-8250345    mdykaufman@clalit.org.il   
Sponsors and Collaborators
Carmel Medical Center
More Information
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Responsible Party: Moran Paz, M.D., Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01637974    
Other Study ID Numbers: CMC-11-0050-CTIL
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Gynatresia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases