Clinical trial · Interventional
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SprayShield™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SprayShield™
- description
- SprayShield™
- interventionNames
- Device: SprayShield™
- type
- NO_INTERVENTION
- label
- Control
- description
- No adhesion barrier administered.
Primary outcomes (4)
- measure
- Number of Sites Adherent to the Uterus
- timeFrame
- 8-12 weeks post myomectomy
- description
- The number of times an adhesion is attached to the uterus.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available