Endoscopic Therapy Or Surgery for Early Colon Cancer

Sponsor
Norwegian Department of Health and Social Affairs
Study ID
NCT06940947
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • eFTR — PROCEDURE
    endoscopic full thickness resection
  • Surgery — PROCEDURE
    standard-of-care surgery

Study Details

The trial is a randomized head-to-head comparison of the benefits, harms and burdens of endoscopic full-thickness resection (eFTR), a novel, minimally invasive endoscopic treatment modality, for early colon cancer as compared to standard-of-care surgery.

Key Dates

First listed
Apr 23, 2025
Start date
Aug 25, 2025
Status verified
Nov 2025
Primary completion
Sep 1, 2033
Completion
Sep 1, 2033

Study Design

Enrollment
434 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: eFTR
    endoscopic full thickness resection
  • Active Comparator: Surgery
    standard-of-care surgery

Primary Outcome Measure

Rate of severe adverse events, re-admissions and deaths within 30 days [ Time Frame: 30 days ]

Central Contacts

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