To Assess the Anti-adhesive Effect and Safety of Protescal

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01810900

Enrollment

Registered

2013-03-14

Start date

2012-09-30

Completion date

2013-12-31

Last updated

2016-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Myomectomy

Keywords

anti-adhesive effect and safety, laparoscopic myomectomy

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.

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.

Interventions

DEVICEProtescal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026