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

Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study

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

Study Overview

• Status: Unknown
• Conditions: Asherman Syndrome; Uterine Myoma; Endometrial Polyp
• Intervention / Treatment: Drug: INTERCOAT administration

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moran PAZ, M.D.; Phone Number: 972-4-8250637; Email: MORANPA@CLALIT.GOV.IL
• Study Contact Backup: Name: Yuval Kaufman, M.D.; Phone Number: 972-4-8250345; Email: mdykaufman@clalit.org.il

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Carmel Medical Center
    • Contact: Moran Paz, MD; Phone Number: 972-4-8250637; Email: MORANPA@CLALIT.ORG.IL
    • Contact: Yuval Kaufman, MD; Phone Number: 972-4-8250345; Email: mdykaufman@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: INTERCOAT
NO_INTERVENTION: without INTERCOAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy	one year

Collaborators and Investigators

• Sponsor: Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ANTICIPATED): March 1, 2016
• Study Completion (ANTICIPATED): March 1, 2016

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (ESTIMATE): July 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Gynatresia
• Other Study ID Numbers: CMC-11-0050-CTIL