Hybrid APC Assisted EMR for Large Colon Polyps

NCT03390907 | Completed Results FDA Device

• 1 other identifier: STUDY00008877
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to evaluate and examine whether use of Hybrid Argon Plasma Coagulation (APC) as an adjunct to endoscopic mucosal resection (EMR) will reduce the risk of residual or recurrent neoplasia at 6 months. Hybrid APC is an existing FDA approved device used to assist with ablation of abnormal tissue anywhere in the GI tract.

Conditions

Colon Polyp; Colon Adenoma; Colon Cancer

Keywords

Colon polyp; EMR; Hybrid-APC; Laterally spreading tumor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Having Complete Resection

  The primary outcome of interest will be the percentage of participants having complete resection at 6 months.

  6 months post initial procedure

Secondary Outcomes (1)

• Measure of Within 30 Days of Procedure Adverse Events ( Post-polypectomy Bleeding and Post-polypectomy Syndrome)

  30 days

Study Arms (1)

Hybrid APC

EXPERIMENTAL

Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.

Device: Hybrid APC

Interventions

Hybrid APC DEVICE

Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.

Hybrid APC

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient aged ≥18 and ≤89 of any gender, ethnicity and race referred to endoscopy for resection of large colon polyps
• Patients with a ≥20mm colon non-pedunculated polyp
• Ability to give written informed consent

You may not qualify if:

• Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
• Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
• Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
• Patients with inflammatory bowel disease
• Patients who are receiving an emergency colonoscopy
• Poor general health (ASA class\>3)
• Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
• Poor bowel preparation
• Target sign or perforation during initial EMR
• Need for ESD for complete resection prior to APC
• Pregnancy

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr. John Levenick
• Organization: Penn State Milton S. Hershey Medical Center

jlevenick@pennstatehealth.psu.edu

717-531-3834

Study Officials

• John Levenick, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Following Standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This is a pilot study design in which patients with non-pedunculated large polyps ≥ 20mm undergoing EMR will be recruited. Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base edges of the polypectomy site to fulgurate any potential microscopic residual disease.

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 4, 2018
• Study Start: September 28, 2018
• Primary Completion: October 27, 2020
• Study Completion: October 27, 2020
• Last Updated: November 8, 2021
• Results First Posted: November 8, 2021

Record last verified: 2021-11

Locations

US (1)