To Assess the Anti-adhesive Effect and Safety of Protescal

This study is currently recruiting participants.
Verified March 2013 by LG Life Sciences
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01810900
First received: March 12, 2013
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Laparoscopic Myomectomy
Device: Protescal
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • presence/absence of postoperative adhesions at second-look procedure [ Time Frame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: September 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protescal
Protescal is applied to this arm.
Device: Protescal
No Intervention: non-treatment

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810900

Locations
Korea, Republic of
Hanyang University Hospital Recruiting
Seoul, Korea, Republic of, 133-791
Contact: Joongsub Choi, M.D., Ph.D.    +82-2290-8416    choiyjjy1@hanyang.ac.kr   
Principal Investigator: Joongsub Choi, M.D., Ph.D.         
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01810900     History of Changes
Other Study ID Numbers: LG-ABCL002
Study First Received: March 12, 2013
Last Updated: March 13, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by LG Life Sciences:
anti-adhesive effect and safety, laparoscopic myomectomy

ClinicalTrials.gov processed this record on April 17, 2014