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

Primary Purpose

Asherman Syndrome, Endometrial Polyp, Uterine Myoma

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
INTERCOAT administration
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asherman Syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

with INTERCOAT

without INTERCOAT

Arm Description

injection of intercoat into the euterine cavity at the end of hysteroscopy

without INTERCOAT

Outcomes

Primary Outcome Measures

Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy

Secondary Outcome Measures

Full Information

First Posted
July 9, 2012
Last Updated
July 30, 2015
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01637974
Brief Title
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery
Official Title
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asherman Syndrome, Endometrial Polyp, Uterine Myoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
with INTERCOAT
Arm Type
Experimental
Arm Description
injection of intercoat into the euterine cavity at the end of hysteroscopy
Arm Title
without INTERCOAT
Arm Type
No Intervention
Arm Description
without INTERCOAT
Intervention Type
Drug
Intervention Name(s)
INTERCOAT administration
Other Intervention Name(s)
INTERCOAT
Intervention Description
Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery
Primary Outcome Measure Information:
Title
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moran PAZ, M.D.
Phone
972-4-8250637
Email
MORANPA@CLALIT.GOV.IL
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Kaufman, M.D.
Phone
972-4-8250345
Email
mdykaufman@clalit.org.il
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moran Paz, MD
Phone
972-4-8250637
Email
MORANPA@CLALIT.ORG.IL
First Name & Middle Initial & Last Name & Degree
Yuval Kaufman, MD
Phone
972-4-8250345
Email
mdykaufman@clalit.org.il

12. IPD Sharing Statement

Learn more about this trial

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

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