Status:
COMPLETED
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Fibroid
Myoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good su...
Eligibility Criteria
Inclusion
- Females, 18 years of age or older, of child-bearing potential.
- Subject has at least one myoma \>= 3 cm.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00891657
Start Date
November 1 2008
End Date
May 1 2009
Last Update
September 7 2017
Active Locations (1)
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1
Pius Clinic
Oldenburg, Germany