To Assess the Anti-adhesive Effect and Safety of Protescal

LG Life Sciences

Status and phase: Terminated; Phase 3

Conditions: Laparoscopic Myomectomy

Treatments: Device: Protescal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01810900

LG-ABCL002

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Protescal

Experimental group

Description:

Protescal is applied to this arm.

Treatment:

Device: Protescal

non-treatment

No Intervention group