NCT01745432

Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• UTERINE MYOMAS

Interventions

Type	Name	Description
DEVICE	ADBLOCK	Laparoscopic surgery

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2012-12-10
• Last updated: 2016-07-06

Locations

3 sites across 1 country: Germany