To Assess the Anti-adhesive Effect and Safety of Protescal
Sponsor
LG Life Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT01810900
Collaborator
(none)
50
1
2
15
3.3
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Study Type:
Interventional
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
:
Sep 1, 2012
Actual Primary Completion Date
:
Nov 1, 2013
Actual Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Protescal Protescal is applied to this arm. |
Device: Protescal
|
| No Intervention: non-treatment
|
Outcome Measures
Primary Outcome Measures
- presence/absence of postoperative adhesions at second-look procedure [at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hanyang University Hospital | Seoul | Korea, Republic of | 133-791 |
Sponsors and Collaborators
- LG Life Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01810900
Other Study ID Numbers:
- LG-ABCL002
First Posted:
Mar 14, 2013
Last Update Posted:
Mar 11, 2016
Last Verified:
Nov 1, 2014
Keywords provided by LG Life Sciences