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
About this trial
This is an interventional prevention trial for Asherman Syndrome
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
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
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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