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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 2, 2013
Last verified: December 2013
  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:


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: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (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

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
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, see Learn About Clinical Studies.

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 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: December 2, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Uterine Neoplasms
Polyps
Gynatresia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014