We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Moran Paz, Carmel Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637974
First Posted: July 11, 2012
Last Update Posted: July 31, 2015
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.
Information provided by (Responsible Party):
Moran Paz, Carmel Medical Center
  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
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

Resource links provided by NLM:


Further study details as provided by Moran Paz, Carmel Medical Center:

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

Estimated Enrollment: 130
Study Start Date: December 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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
without INTERCOAT

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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
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

Responsible Party: Moran Paz, M.D., Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01637974     History of Changes
Other Study ID Numbers: CMC-11-0050-CTIL
First Submitted: July 9, 2012
First Posted: July 11, 2012
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Gynatresia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Genital Diseases, Female