Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Endoscopic Mucosal Resection; Polyp of Colon

Treatments: Procedure: Cold EMR; Procedure: Hybrid EMR

Study type: Interventional

Funder types: Other

Identifiers

NCT06937671

25-126

Details and patient eligibility

About

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.

Enrollment: 194 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient (age 18 years or older)
• Polyp size of at least 20 mm
• - Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)

Exclusion criteria

• Polyps with previous failed resection attempts or polyp recurrence
• Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma)
• Polyps with nodules too large (>1-1.5cm) for the use of a cold snare
• Inflammatory bowel disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Cold EMR

Active Comparator group

Description:

Control group patients that receive standard cold EMR treatment.

Treatment:

Procedure: Cold EMR

Hybrid cold EMR

Experimental group

Description:

Intervention group patients. Patients will receive hybrid EMR treatment.

Treatment:

Procedure: Hybrid EMR