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

N/ANot Yet RecruitingNCT07311590

JurongHealth4 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Colon Polyp

Interventions

Colonic Intraluminal Endoscopic Support StructureDEVICE

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:

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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"

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

Data from ClinicalTrials.gov

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