UTERINE MYOMAS Clinical Trial
Official title:
Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery
Adhesions are the most frequent complication of abdominopelvic surgery. They are internal
scar tissues which form as a result of surgery which may abnormally join together what were
once separate tissues and organs.
This study will assess the safety and usability of anti-adhesion agent (gel) when used after
laparoscopic surgery.
The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse
events in ADBLOCK and surgery only group) assessed at 28 days
Title: Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in
Laparoscopic Gynaecological surgery
Design: Randomised controlled study to assess the safety, manageability and usability of
ADBLOCK when used as an adjunct to laparoscopic surgery for the primary removal of
('virgin') myomas in women wishing to improve pregnancy outcomes.
Use of ADBLOCK will be assessed against laparoscopic surgery alone in 30 patients
(randomised 2:1 ADBLOCK/surgery) with a pneumoperitoneum ≤90minutes.
Clinical Site Locations:
- Oldenburg, Germany
- Neuss, Germany
- Berlin, Germany
Patient Population: Women who have not completed their family planning and who are
undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy
outcomes.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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