A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Fibroid, Myoma, Leiomyoma
Female
Fibroid, Myoma, Leiomyoma
Trial Information
A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
Inclusion Criteria:
- Females, 18 years of age or older, of child-bearing potential.
- Subject has at least one myoma >= 3 cm.
Exclusion Criteria:
- Pregnant or lactating females.
- Females undergoing prior open or closed myomectomy for treatment of myomas.
- Evidence of current active endometriosis or infection
- History of or active inflammatory bowel disease or pelvic inflammatory disease.
- Presence of a frozen pelvis, or hydrosalpinges.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
Number of Sites Adherent to the Uterus
Outcome Description:
The number of times an adhesion is attached to the uterus.
Outcome Time Frame:
8-12 weeks post myomectomy
Safety Issue:
Yes
Principal Investigator
Rudy Leon De Wilde, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Pius Clinic
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
GYN-08-002
NCT ID:
NCT00891657
Start Date:
November 2008
Completion Date:
May 2009
Related Keywords:
- Fibroid
- Myoma
- Leiomyoma
- Adhesion
- Fibroid
- Myoma
- Leiomyoma
- Myomectomy
- Tissue Adhesions
- Leiomyoma
- Myofibroma
- Myoma
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