The Efficacy and Safety of Elastic Traction Device for Endoscopic Submucosal Dissection of Gastric Tumor

The Efficacy and Safety of Elastic Traction Device for Endoscopic Submucosal Dissection of Gastric Neoplasm: a Multi-Center, Prospective, Clinical Trial (Pilot Study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011720

Enrollment

120

Registered

2026-03-12

Start date

2026-01-28

Completion date

Unknown

Last updated

2026-03-16

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

Conditions

None listed

Interventions

Medical Device : During endoscopic submucosal dissection (ESD) for gastric neoplasms (adenoma or early gastric cancer), after precutting, a clip–band device (investigational device) is attached to the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women aged 20–80 years who have gastric lesions (adenoma or adenocarcinoma) that meet the indications for endoscopic resection (absolute or expanded indications) and have no contraindications to the procedure.

Exclusion criteria

Exclusion criteria: (1) Lesion size < 1 cm (small lesions can be easily removed by snaring) (2) Presence of an acute infectious disease (3) Pregnant or breastfeeding women (4) Presence of severe psychiatric illness (5) History of acute myocardial infarction or coronary artery disease within the past 6 months (6) Inability to discontinue antiplatelet agents (except low-dose aspirin) or anticoagulants (warfarin or NOACs) prior to the procedure (7) Patients expected to be unable to cooperate during the procedure (8) Refusal of the participant to participate in the study

Design outcomes

Primary

Measure	Time frame
Procedural success indicators of traction-assisted ESD using an Elastic Traction Band (ETB)	—

Secondary

Measure	Time frame
Procedural success indicators of traction-assisted ESD using an Elastic Traction Band (ETB) (en bloc resection rate, complete resection rate, and curative resection rate);Procedure time (total procedure time, lesion incision time, and clip placement time);Post-procedure questionnaire after band-clip application (overall usefulness during the procedure, difficulty in attaching the clip to the lesion, and difficulty in removing or retrieving the band-clip after the procedure)	—

Measure

Time frame

Procedural success indicators of traction-assisted ESD using an Elastic Traction Band (ETB) (en bloc resection rate, complete resection rate, and curative resection rate);Procedure time (total procedure time, lesion incision time, and clip placement time);Post-procedure questionnaire after band-clip application (overall usefulness during the procedure, difficulty in attaching the clip to the lesion, and difficulty in removing or retrieving the band-clip after the procedure)

—

Countries

Korea, Republic of

Contacts

Public ContactCheol Min Shin

Seoul National University Bundang Hospital

scm6md@gmail.com+82-31-787-7057

Outcome results