Colon PolypNCT07311590

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

A study testing Colonic Intraluminal Endoscopic Support Structure in people with Colon Polyp, run by JurongHealth.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

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 Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Colon Polyp
What is being tested?: Colonic Intraluminal Endoscopic Support Structure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: No sites listed yet
Study dates: 18 Dec 2025to 18 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Positive fecal occult blood test
ASA I/II
only patients with left-sided colonic polyp during colonoscopy will be included into the study eventually

Who cannot join

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

About this study

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

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

Conditions: Colon Polyp
Being tested: Colonic Intraluminal Endoscopic Support Structure
Medical subject headings: Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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:

Study groups in NCT07311590
Study group	Role	What they receive
Colonoscopy and polypectomy with Colonic Intraluminal Endoscopic Support Structure in-situ	Experimental	Not described Receives: Device: Colonic Intraluminal Endoscopic Support Structure

What is being measured

The primary outcome is the main question the study is designed to answer.

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"
Measured: From enrollment to end of treatment at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 202518 Dec 2026

First posted31 Dec 2025
Study start18 Dec 2025 (estimated)
Primary completion18 Dec 2026 (estimated)
Study completion18 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colon PolypStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07311590
Sponsor's protocol ID: 2025/1074
Status last verified: Dec 2025
First submitted: 8 Dec 2025
Last updated: 31 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp

All Colon Polyp trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07311590
Acronym / sponsor ID: 2025/1074
Conditions: Colon Polyp
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 4 participants (estimated)
Lead sponsor: JurongHealthOther government
Study start: 18 Dec 2025 (estimated)
Primary completion: 18 Dec 2026 (estimated)
Study completion: 18 Dec 2026 (estimated)
First posted: 31 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Colonoscopy and polypectomy with Colonic Intraluminal Endoscopic Support Structure in-situ	Experimental	Device: Colonic Intraluminal Endoscopic Support Structure

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Positive fecal occult blood test

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Colonic Intraluminal Endoscopic Support StructureDuring 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:	Device	Colonoscopy and polypectomy with Colonic Intraluminal Endoscopic Support Structure in-situ

Primary outcome

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"

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.

Related trials for Colon Polyp

Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Colonic Intraluminal Endoscopic Support Structure in people with Colon Polyp, run by JurongHealth.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability to deploying CIESS in a single attempt (time frame: From enrollment to end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07311590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.