Evaluation of the Utility and Safety of a Novel Multipoint Traction Clip in Endoscopic Submucosal Dissection (ESD)

Evaluation of the usefulness and safety of a novel traction clip in endoscopic submucosal dissection (ESD). - Verification of usefulness and safety of new traction clips

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053384

Enrollment

Registered

2024-01-18

Start date

2022-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

gastrointestinal neoplasms

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who will be eligible for insurance coverage of endoscopic submucosal dissection between March 1 and December 31, 2022, and who have been fully informed about their participation in the study, and who have given their free and voluntary consent to be treated with the new device based on their full understanding of the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria include suspected disseminated intravascular coagulation syndrome, severe heart failure, active thromboembolism at the time of study entry, severe respiratory failure, pregnancy or women of childbearing potential, and other subjects deemed unsuitable by the study investigator (subinvestigator).

Design outcomes

Primary

Measure	Time frame
Time to apply new instruments and completion rate	—

Secondary

Measure	Time frame
Treatment time, batch resection rate, amount of local fluid used, and frequency of incidentalities (treatment-related bleeding, post-treatment hemorrhage, perforation)	—

Countries

Japan

Contacts

Public ContactTakuma Okamura

Nagasaki Harbor Medical Center gastroenterology

taku.okamu1002@gmail.com0958223251

Outcome results