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Not yet recruiting NCT07311590

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

No phase Interventional Colon Polyp

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colonic Intraluminal Endoscopic Support Structure.
Who it may be relevant to
Registry conditions: Colon Polyp. Basic parameters: 21 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

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

Interventions

  • Device 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:

Primary outcome measures

  • Ability to deploying CIESS in a single attempt [Time frame: From enrollment to end of treatment at 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07311590 · 2025/1074

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗