Colon Cancer PreventionNCT07328308
Delayed Surveillance Colonoscopy Following Piecemeal EMR
A study testing Colonoscopy after bowel cleansing in people with Colon Cancer Prevention and Polyp Colorectal, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
This multicenter, prospective, randomized non inferiority trial, conducted at four Israeli hospitals, will evaluate whether a relaxed surveillance strategy after piecemeal endoscopic mucosal resection (pEMR) of large non pedunculated colorectal polyps (LNPCPs, ≥20 mm) is as safe and effective as the current standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer Prevention, Polyp Colorectal
- What is being tested?
- Colonoscopy after bowel cleansing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2026to Jan 2031
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Undergoing pEMR of LNPCPs
- Able to provide informed consent and comply with follow-up requirements
Who cannot join
- Patients with invasive cancer identified during the index procedure
- en bloc resection
- Patients unable to attend follow-up colonoscopies due to comorbid conditions
- Patients who require additional surgery for polyp removal or other complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Rambam Medical Center
Haifa
Klein, +972-4-7773625, am_klein@rmc.gov.il
Klein, MD
About this study
Official title: Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study
This multicenter, prospective, randomized non inferiority trial, conducted at four Israeli hospitals, will evaluate whether a relaxed surveillance strategy after piecemeal endoscopic mucosal resection (pEMR) of large non pedunculated colorectal polyps (LNPCPs, ≥20 mm) is as safe and effective as the current standard intensive surveillance. Approximately 760 adults undergoing complete pEMR with margin ablation will be randomized 1:1 into:
Standard Surveillance: Colonoscopy at 6, 18, and 48 months
Read more
Relaxed Surveillance: Colonoscopy at 12 and 48 months
All colonoscopies will be performed using high definition white light and narrow band imaging, with biopsies obtained only if recurrence is suspected. The investigators hypothesize that a relaxed surveillance strategy will be non inferior to the current standard intensive surveillance. If non inferiority is demonstrated, the study may support guideline changes toward reduced surveillance frequency after pEMR with margin ablation, potentially decreasing patient burden and healthcare costs.
- Conditions
- Colon Cancer Prevention, Polyp Colorectal
- Being tested
- Colonoscopy after bowel cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy after bowel cleansingProcedure or surgery
The procedure is performed by experienced endoscopists using high-definition white light and narrow-band imaging to carefully inspect the colon and assess the resection site. Biopsies are taken only if abnormal tissue or recurrence is suspected.
| Study group | Role | What they receive |
|---|---|---|
| Standard Surveillance Group | Active comparator | Participants undergo colonoscopy at 6, 18, and 48 months after piecemeal EMR. Receives: Procedure: Colonoscopy after bowel cleansing |
| Relaxed Surveillance Group | Experimental | Participants undergo colonoscopy at 12 and 48 months after piecemeal EMR. Receives: Procedure: Colonoscopy after bowel cleansing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy.
Measured: From patient enrollment until the end of the 48 month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Klein MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328308
- Sponsor's protocol ID
- RMB-0069-25
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Surveillance Colonoscopy Following Piecemeal EMR - a Randomized Study
- ClinicalTrials.gov ID
- NCT07328308
- Acronym / sponsor ID
- RMB-0069-25
- Conditions
- Colon Cancer Prevention, Polyp Colorectal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 9 Jan 2026 (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.
This multicenter, prospective, randomized non inferiority trial, conducted at four Israeli hospitals, will evaluate whether a relaxed surveillance strategy after piecemeal endoscopic mucosal resection (pEMR) of large non pedunculated colorectal polyps (LNPCPs, ≥20 mm) is as safe and effective as the current standard intensive surveillance. Approximately 760 adults undergoing complete pEMR with margin ablation will be randomized 1:1 into:
Standard Surveillance: Colonoscopy at 6, 18, and 48 months
Relaxed Surveillance: Colonoscopy at 12 and 48 months
All colonoscopies will be performed using high definition white light and narrow band imaging, with biopsies obtained only if recurrence is suspected. The investigators hypothesize that a relaxed surveillance strategy will be non inferior to the current standard intensive surveillance. If non inferiority is demonstrated, the study may support guideline changes toward reduced surveillance frequency after pEMR with margin ablation, potentially decreasing patient burden and healthcare costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Surveillance Group | Active comparator | Procedure: Colonoscopy after bowel cleansingParticipants undergo colonoscopy at 6, 18, and 48 months after piecemeal EMR. |
| Relaxed Surveillance Group | Experimental | Procedure: Colonoscopy after bowel cleansingParticipants undergo colonoscopy at 12 and 48 months after piecemeal EMR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older
- Undergoing pEMR of LNPCPs
- Able to provide informed consent and comply with follow-up requirements
Key exclusion criteria (4 listed)
- Patients with invasive cancer identified during the index procedure
- en bloc resection
- Patients unable to attend follow-up colonoscopies due to comorbid conditions
- Patients who require additional surgery for polyp removal or other complications
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 |
|---|---|---|
| Colonoscopy after bowel cleansingThe procedure is performed by experienced endoscopists using high-definition white light and narrow-band imaging to carefully inspect the colon and assess the resection site. Biopsies are taken only if abnormal tissue or recurrence is suspected. | Procedure or surgery | Relaxed Surveillance Group, Standard Surveillance Group |
Primary outcome
Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy.
Time frame: From patient enrollment until the end of the 48 month follow up period
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 9 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy after bowel cleansing in people with Colon Cancer Prevention and Polyp Colorectal, run by Rambam Health Care Campus at 1 site in Israel.
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 4 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 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Klein (+972-4-7773625, am_klein@rmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy. (time frame: From patient enrollment until the end of the 48 month follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.