A multi-center open-label randomized controlled trial to evaluate the efficacy of the Mantis Clip for defect closure following colorectal endoscopic submucosal dissection

A multi-center open-label randomized controlled trial to evaluate the efficacy of the Mantis Clip for defect closure following colorectal endoscopic submucosal dissection - A multi-center open-label randomized controlled trial to evaluate the efficacy of the Mantis Clip for defect closure following colorectal endoscopic submucosal dissection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000054070

Enrollment

250

Registered

2024-04-08

Start date

2024-05-27

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

Colorectal neoplasia

Interventions

MANTIS Clip closure group: Defect closure after colorectal ESD is performed using Mantis Clip and conventional clip. Conventional clip closure group: Defect closure after colorectal ESD is performed u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Lesions meeting the indication criteria for colorectal ESD 2. Lesions with a diameter estimated to be 20 mm or larger by preoperative endoscopic evaluation

Exclusion criteria

Exclusion criteria: - Patients who do not give consent for the study - Patients with lesions involving anal verge - Patients with lesions involving terminal ileum - Patients undergoing endoscopic resection for multiple lesions - Patients with lesions more than 2/3 of the lumen - Patients with nickel hypersensitivity - Patients who are not managed according to guidelines regarding perioperative withdrawal of antithrombotic therapy - Patients with coagulopathy at high risk of bleeding - Patients who are pregnant - Patients who are judged unsuitable for participation by the doctors

Design outcomes

Primary

Measure	Time frame
The complete defect closure rate	—

Secondary

Measure	Time frame
- Closure time (min) - Closure speed (mm2/min) - Post-ESD complication rate (delayed bleeding, delayed perforation, Post-ESD coagulation syndrome) (%) - The rate of complication related to closure procedure (%)	—

Countries

Japan

Contacts

Public ContactNaoya Tada

The Jikei University School of Medicine Department of Endoscopy

naoya6295@outlook.jp0334331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026