N/A
N=15
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
Fibroid · Myoma · Leiomyoma
Bottom Line
View on ClinicalTrials.gov: NCT00891657 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Aug 2010
Primary outcome: Primary: Number of Sites Adherent to the Uterus — 1.1; 0.6 Adhesion Sites
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SprayShield™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Sites Adherent to the Uterus |
1.1; 0.6 | — |
| PRIMARY Mean Severity Score of Sites Adherent to the Uterus |
1.63; 0.8 | — |
| PRIMARY Mean Extent Score of Sites Adherent to the Uterus |
0.92; 0.6 | — |
| PRIMARY Area of Sites Adherent to the Uterus (cm^2) |
2.19; 2.7 | — |
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 surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00891657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.