Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

Conditions

• Endoscopic Mucosal Resection
• Polyp of Colon

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cold EMR — PROCEDURE
  Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
• Hybrid EMR — PROCEDURE
  Cold EMR with hot avulsion of any visible residual neoplasia within the resection bed, in addition to precise APC of the fibrotic bands that may harbor invisible neoplasia within the resection bed.

Study Details

The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps. Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.

Key Dates

Start date

May 1, 2025

Status verified

Apr 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

194 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Cold EMR
  Control group patients that receive standard cold EMR treatment.
• Experimental: Hybrid cold EMR
  Intervention group patients. Patients will receive hybrid EMR treatment.

Primary Outcome Measure

Recurrence of polyps [ Time Frame: 3-6 months after the procedure ]

Central Contacts

• Akram Ahmad, M.D.
  954-659-5000
  [email protected]
• Michael Nicolas, B.S.
  9546596213
  [email protected]

Locations (2)

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