To Assess the Anti-adhesive Effect and Safety of Protescal

Phase 3TerminatedNCT01810900

LG Life Sciences50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Laparoscopic Myomectomy

Interventions

ProtescalDEVICE

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Hanyang University Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

presence/absence of postoperative adhesions at second-look procedure

Time frame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy

Data from ClinicalTrials.gov

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