A First-in-human Clinical Trial Evaluating a Novel Colonic Intraluminal Endoscopic Support Structure (CIESS)

JurongHealth

Status: Not yet enrolling

Conditions: Colon Polyp

Treatments: Device: Colonic Intraluminal Endoscopic Support Structure

Study type: Interventional

Funder types: Other

Identifiers

NCT07311590

2025/1074

Details and patient eligibility

About

The aim of the first-in-human clinical trial is to evaluate the feasibility of performing colonoscopic polypectomy with a novel colonic intraluminal endoscopic support structure (CIESS) in-situ

Enrollment: 4 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive fecal occult blood test

  • ASA I/II
  • only patients with left-sided colonic polyp during colonoscopy will be included into the study eventually

Exclusion criteria

• History of malignancy, gastrointestinal tract/ abdominal surgery, diverticular disease, abdominal/ pelvic radiation
• Pregnancy patient
• cognitively impaired patients
• Patients on blood thinners or anticoagulants
• ASA III / ASA IV

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Colonoscopy and polypectomy with Colonic Intraluminal Endoscopic Support Structure in-situ

Experimental group

Treatment:

Device: Colonic Intraluminal Endoscopic Support Structure