To Assess the Anti-adhesive Effect and Safety of Protescal

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014