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

NCT ID: NCT07311590

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-18

Study Completion Date

2026-12-18

Brief Summary

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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

Detailed Description

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Conditions

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Colon Polyp

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Colonic Intraluminal Endoscopic Support Structure

Intervention Type 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:

Interventions

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Colonic Intraluminal Endoscopic Support Structure

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:

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JurongHealth

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2025/1074

Identifier Type: -

Identifier Source: org_study_id