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To Assess the Anti-adhesive Effect and Safety of Protescal

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01810900
First Posted: March 14, 2013
Last Update Posted: March 11, 2016
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.
Information provided by (Responsible Party):
LG Life Sciences
  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
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.
  Eligibility

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT01810900


Locations
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
ClinicalTrials.gov Identifier: NCT01810900     History of Changes
Other Study ID Numbers: LG-ABCL002
First Submitted: March 12, 2013
First Posted: March 14, 2013
Last Update Posted: March 11, 2016
Last Verified: November 2014

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