Suspended
To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery
What is being tested
Protescal
Device
Who is being recruted
Over 20 Years
+3 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 3
Interventional
Study Start: September 2012
Summary
Principal SponsorLG Life Sciences
Last updated: March 11, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorLG Life Sciences
Last updated: March 11, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Female
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
a woman who is over 20 years old
a woman who needs a laparoscopic myomectomy
1 exclusion criteria prevent from participating
a pregnant woman and a nursing mother
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalProtescal is applied to this arm.
Group II
No InterventionStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center