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

NCT07311590 | Not Yet Recruiting

• 1 other identifier: 2025/1074
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colon Polyp

Outcome Measures

Primary Outcomes (1)

• Ability to deploying CIESS in a single attempt

  Primary outcome measure is whether the CIESS can be deployed successfully in a single attempt - this is a measure of the feasibility of deploying the CIESS during colonoscopy. This outcome will be recorded as "successfully deployed in a single attempt or unsuccessfully deployed in a single attempt"

  From enrollment to end of treatment at 4 weeks

Study Arms (1)

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

EXPERIMENTAL

Device: Colonic Intraluminal Endoscopic Support Structure

Interventions

Colonic Intraluminal Endoscopic Support Structure DEVICE

During colonoscopy, if a left-sided colonic polyps is identified, the colonic intraluminal endoscopic support structure (CIESS) will be deployed. Routine polypectomy will be performed. CIESS will be retrieved after polypectomy is completed. Colonoscopy will be completed as per normal routine.Other Name:

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

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• JurongHealth: lead

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 31, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12