Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions

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.
 
ClinicalTrials.gov Identifier: NCT01377779
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date  ICMJE June 15, 2011
First Posted Date  ICMJE June 21, 2011
Last Update Posted Date June 21, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
safety of intrauterine application of Intercoat [ Time Frame: 18 months ]
women treated by Intercoat following their hysteroscopic procedure were followed for immediate and late adverse effects; fever, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception [ Time Frame: 14 months ]
intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions
Official Title  ICMJE Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study
Brief Summary This is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception.
Detailed Description Thirty women randomly divided equally into those who received Intercoat following hysteroscopic treatment for retained products of conception (study group) and those who did not receive the gel (controls). Safety and efficacy of the preparation were evaluated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Asherman Syndrome
Intervention  ICMJE
  • Drug: Oxiplex/AP gel
    Intrauterine application of Intercoat following hysteroscopy
    Other Name: Intercoat
  • Drug: Normal Saline
    No intrauterine application of Intercoat following hysteroscopy
    Other Name: Distention media
Study Arms  ICMJE
  • Experimental: Intercoat treatment
    women treated by Intercoat gel following hysteroscopy for retained products of conception
    Intervention: Drug: Oxiplex/AP gel
  • Placebo Comparator: Control group
    No additional treatment following hysteroscopy was performed
    Intervention: Drug: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2011)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18 and 50 years
  • Availability of the results of vaginal ultrasound or diagnostic hysteroscopy

Exclusion Criteria:

  • Signs of infection upon admission
  • Ongoing pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01377779
Other Study ID Numbers  ICMJE 2*13/09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Moty Pansky, MD, Asaf Harofe MC
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Moty Pansky, MD Asaf Harofe MC
PRS Account Assaf-Harofeh Medical Center
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP