NCT04007211

Brief Summary

This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

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

February 27, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

July 1, 2019

Last Update Submit

August 24, 2020

Conditions

Postoperative Adhesion of Uterus

Outcome Measures

Primary Outcomes (1)

  • Incidence of intrauterine adhesion

    Incidence rate of intrauterine adhesion after surgery

    4 weeks

Study Arms (2)

ABT13107

EXPERIMENTAL
Device: ABT13107

Hyalobarrier

ACTIVE COMPARATOR
Device: Hyalobarrier

Interventions

ABT13107DEVICE

Dose: 3mL, maximum 10mL

ABT13107
HyalobarrierDEVICE

Dose: 10mL

Hyalobarrier

Eligibility Criteria

Age19 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged from 19 to 70
  • Those who are scheduled for hysteroscopy to treat the following diseases: submucosal myomas, endometrial polyps, intrauterine adhesion etc.

You may not qualify if:

  • Those who will apply other intrauterine device rather than investigational device during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Lee DY, Lee SR, Kim SK, Joo JK, Lee WS, Shin JH, Cho S, Park JC, Kim SH. A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial. Yonsei Med J. 2020 Oct;61(10):868-874. doi: 10.3349/ymj.2020.61.10.868.

    PMID: 32975061DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

February 27, 2017

Primary Completion

August 29, 2018

Study Completion

August 29, 2018

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

KR(1)