To Assess the Anti-adhesive Effect and Safety of Protescal

Phase 3

Terminated

• Conditions: Laparoscopic Myomectomy
• Interventions: Device: Protescal

• Registration Number: NCT01810900
• Lead Sponsor: LG Life Sciences

Brief Summary

This multicenter, randomized, single-blind study assessed the safety and efficacy of Protescal for the reduction of post-operative adhesion formation following myomectomy.

Detailed Description

The age of the patients participating in the study overed 20 years and included nonpregnant women requiring laparoscopic myomectomy and expected to undergo a second-look laparoscopy as part of their treatment plan 5 weeks after the initial surgery.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-14
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• a woman who is over 20 years old
• a woman who needs a laparoscopic myomectomy

Exclusion Criteria

• a pregnant woman and a nursing mother

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protescal	Protescal	Protescal is applied to this arm.

Primary Outcome Measures

Name	Time	Method
presence/absence of postoperative adhesions at second-look procedure	at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy

Trial Locations

Locations (1)

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of