To Assess the Anti-adhesive Effect and Safety of Protescal

Laparoscopic Myomectomy Clinical Trial

Official title:

To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01810900
• Other study ID #: LG-ABCL002
• Status: Terminated
• Phase: Phase 3
• First received: March 12, 2013
• Last updated: March 9, 2016
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laparoscopic Myomectomy

Intervention

Device:
• Protescal

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence/absence of postoperative adhesions at second-look procedure		at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy	Yes