Leiomyoma Clinical Trial
Official title:
A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
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 surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.
Status | Completed |
Enrollment | 15 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | Pius Clinic | Oldenburg |
Lead Sponsor | Collaborator |
---|---|
Integra LifeSciences Corporation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Sites Adherent to the Uterus | The number of times an adhesion is attached to the uterus. | 8-12 weeks post myomectomy | Yes |
Primary | Mean Severity Score of Sites Adherent to the Uterus | The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions. | 8-12 weeks post myomectomy | Yes |
Primary | Mean Extent Score of Sites Adherent to the Uterus | 0 =no adhesions, 1=covering <25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering >51% of locations' total area. | 8-12 weeks post myomectomy | No |
Primary | Area of Sites Adherent to the Uterus (cm^2) | 8-12 weeks post myomectomy | No |
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