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To Assess the Anti-adhesive Effect and Safety of Protescal

This study has been terminated.
Information provided by (Responsible Party):
LG Life Sciences Identifier:
First received: March 12, 2013
Last updated: March 9, 2016
Last verified: November 2014
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
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

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 ]

Enrollment: 50
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (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.

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

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

Responsible Party: LG Life Sciences Identifier: NCT01810900     History of Changes
Other Study ID Numbers: LG-ABCL002
Study First Received: March 12, 2013
Last Updated: March 9, 2016

Keywords provided by LG Life Sciences:
anti-adhesive effect and safety, laparoscopic myomectomy processed this record on September 21, 2017