MANTIS study

JRCT ID: jRCT1042240004

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Early colorectal cancer
• Date of first enrollment: 16/04/2024
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Early colorectal cancer with 30-50 mm in size is enrolled, and perform endoscopic closure using MANTI Clip for mucosal defects after colorectal ESD.

Outcome(s)

• Primary Outcome: Rate of complete closure achieved (At the end of protocol treatment)

Secondary Outcome

1 Closure time
2 Rate of closure maintained at 3-5 days
3 Rate of clip dropout at 2 weeks
4 Adverse events rate
5 Rate of medical device failures

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Early colorectal cancer, size 30-50 mm in endoscopic image
2 Scheduled for treatment with ESD.
3 More than 18 years of age
4 Performance status, 0-1
5 Patients with provided written informed consent

Exclude criteria

1 Patients with bleeding tendency
2 Continuation of more than two antithrombotic
agents during endoscopic resection or
requirement of heparin bridging for past comorbid
illness
3 Patients with nickel sensitivity
4 Patients judged by the study director or resear
cher to be ineligible for the study

Related Information

• Primary Sponsor: Imai Kenichiro