NCT01810900

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 11, 2016

Status Verified

November 1, 2014

Enrollment Period

1.2 years

First QC Date

March 12, 2013

Last Update Submit

March 9, 2016

Conditions

Laparoscopic Myomectomy

Keywords

anti-adhesive effect and safety, laparoscopic myomectomy

Outcome Measures

Primary Outcomes (1)

  • presence/absence of postoperative adhesions at second-look procedure

    at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy

Study Arms (2)

Protescal

EXPERIMENTAL

Protescal is applied to this arm.

Device: Protescal

non-treatment

NO INTERVENTION

Interventions

ProtescalDEVICE
Protescal

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a woman who is over 20 years old
  • a woman who needs a laparoscopic myomectomy

You may not qualify if:

  • a pregnant woman and a nursing mother

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Hospital

Seoul, Seoul, 133-791, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

September 1, 2012

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

March 11, 2016

Record last verified: 2014-11

Locations

KR(1)