Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine

NCT ID: NCT04007211

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2018-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Adhesion of Uterus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABT13107

Group Type EXPERIMENTAL

ABT13107

Intervention Type DEVICE

Dose: 3mL, maximum 10mL

Hyalobarrier

Group Type ACTIVE_COMPARATOR

Hyalobarrier

Intervention Type DEVICE

Dose: 10mL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT13107

Dose: 3mL, maximum 10mL

Intervention Type DEVICE

Hyalobarrier

Dose: 10mL

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Those who will apply other intrauterine device rather than investigational device during the study period.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32975061 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MT10-KR16IUA705

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.