To Assess the Anti-adhesive Effect and Safety of Protescal

March 9, 2016 updated by: LG Life Sciences

To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery

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

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Protescal
Protescal is applied to this arm.
Device: Protescal
NO_INTERVENTION: non-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence/absence of postoperative adhesions at second-look procedure
Time Frame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy
at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (ESTIMATE)

March 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LG-ABCL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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