To Assess the Anti-adhesive Effect and Safety of Protescal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01810900
Recruitment Status : Terminated
First Posted : March 14, 2013
Last Update Posted : March 11, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Laparoscopic Myomectomy Device: Protescal Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery
Study Start Date : September 2012
Primary Completion Date : November 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Protescal
Protescal is applied to this arm.
Device: Protescal
No Intervention: non-treatment

Primary Outcome Measures :
  1. presence/absence of postoperative adhesions at second-look procedure [ Time Frame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01810900

Korea, Republic of
Hanyang University Hospital
Seoul, Korea, Republic of, 133-791
Sponsors and Collaborators
LG Life Sciences

Responsible Party: LG Life Sciences Identifier: NCT01810900     History of Changes
Other Study ID Numbers: LG-ABCL002
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: November 2014

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