ClinicalTrials.gg
Not yet recruitingNCT07328308Updated Jan 9, 2026

Delayed Surveillance Colonoscopy Following Piecemeal EMR

An interventional study of Colonoscopy after bowel cleansing in Colon Cancer Prevention and Polyp Colorectal, sponsored by Rambam Health Care Campus. Not yet recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
760
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Colon Cancer Prevention
  • Polyp Colorectal
03

In context

Colonic Neoplasms

2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.

This study's planned enrollment of 760 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years and older
  • Undergoing pEMR of LNPCPs
  • Able to provide and comply with follow-up requirements

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
760 participants (estimated)

Study arms

  • Active comparator
    Standard Surveillance Group

    Participants undergo colonoscopy at 6, 18, and 48 months after piecemeal EMR.

    Procedure: Colonoscopy after bowel cleansing

  • Experimental
    Relaxed Surveillance Group

    Participants undergo colonoscopy at 12 and 48 months after piecemeal EMR.

    Procedure: Colonoscopy after bowel cleansing

Interventions

  • ProcedureColonoscopy after bowel cleansing

    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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07328308
Responsible party
Amir Klein MD (Principal Investigator, Rambam Health Care Campus) — Principal investigator
First posted
Jan 9, 2026
Start date
Jan 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2031 (estimated)
Last update
Jan 9, 2026

Study contacts

Klein
Contact
am_klein@rmc.gov.il
+972-4-7773625

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion