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

UMIN ID: UMIN000054070

Registered date:08/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Colorectal neoplasia
• Date of first enrollment: 2024/04/08
• Target sample size: 250
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 using conventional clips alone.

Outcome(s)

• Primary Outcome: The complete defect closure rate
• Secondary Outcome: - 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 (%)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: The Jikei University School of Medicine
• Source(s) of Monetary Support: The Jikei University School of Medicine