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

ConditionColon Polyp
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorJurongHealth

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Positive fecal occult blood test

ASA I/II

only patients with left-sided colonic polyp during colonoscopy will be included into the study eventually

Disqualifiers

History of malignancy, gastrointestinal tract/ abdominal surgery, diverticular disease, abdominal/ pelvic radiation

Pregnancy patient

cognitively impaired patients

Patients on blood thinners or anticoagulants

Trial design

Design model

Single group

Treatments tested in this trial

  • 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:

Treatment groups

4 Participants
are divided into 1 treatment group
Group A: Colonoscopy and polypectomy with Colonic Intraluminal Endoscopic Support Structure in-situExperimental treatment 1 intervention

Trial outcomes

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"

Time frame
From enrollment to end of treatment at 4 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: