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

Uterine Myoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01637974
• Other study ID #: CMC-11-0050-CTIL
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2012
• Last updated: July 30, 2015
• Start date: December 2012
• Est. completion date: March 2016

Study information

• Verified date: July 2015
• Source: Carmel Medical Center
• Contact: Moran PAZ, M.D.
• Phone: 972-4-8250637
• Email: MORANPA[@]CLALIT.GOV.IL
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asherman Syndrome
• Endometrial Polyp
• Leiomyoma
• Uterine Myoma

Intervention

Drug:
• INTERCOAT administration
Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy		one year	No