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

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

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Key information

Conditions

Colon Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

Primary outcomes

Ability to deploying CIESS in a single attempt

Time frame: From enrollment to end of treatment at 4 weeks

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"

Sponsors and collaborators

Lead sponsor

JurongHealth

Other Gov

Registry information

Official study title

A First-in-human Clinical Trial Evaluating the Feasibility of Performing Colonoscopic Polypectomy With a Novel Colonic Intraluminal Endoscopic Support Structure (CIESS) In-situ

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Dec 31, 2025
Registry last updated: Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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