Trial Outcomes & Findings for Hybrid APC Assisted EMR for Large Colon Polyps (NCT NCT03390907)

NCT ID: NCT03390907

Last Updated: 2021-11-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 6 months post initial procedure
• Results posted on: 2021-11-08

Participant Flow

Patients in Hershey Medical Center with a known ≥ 20mm polyp detected at a prior colonoscopy who were referred for colonoscopy procedure were identified as potential study participants.

Participant milestones

Measure	Hybrid APC Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hybrid APC Assisted EMR for Large Colon Polyps

Baseline characteristics by cohort

Measure	Hybrid APC n=40 Participants Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
Age, Continuous	64.6 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants
Measurement of polyps in mm	35.2 mm STANDARD_DEVIATION 12.6 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months post initial procedure

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

Outcome measures

Measure	Hybrid APC n=40 Participants Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. 0% of recurrence in 32 cases who completed post-procedure colonoscopy 6 month follow-up.
Percentage of Participants Having Complete Resection	40 Participants

SECONDARY outcome

Timeframe: 30 days

The secondary outcome of interest will be measure of major adverse event rate, mainly post-polypectomy bleeding and post-polypectomy syndrome

Outcome measures

Measure	Hybrid APC n=40 Participants Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. 0% of recurrence in 32 cases who completed post-procedure colonoscopy 6 month follow-up.
Measure of Within 30 Days of Procedure Adverse Events ( Post-polypectomy Bleeding and Post-polypectomy Syndrome)	3 Participants

Adverse Events

Hybrid APC

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hybrid APC n=40 participants at risk Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract. Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
Gastrointestinal disorders Bleeding	7.5% 3/40 • Number of events 3 • At 30 days following the initial resection, the research coordinator called each patient to assess for any signs of post-procedural adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Levenick

Penn State Milton S. Hershey Medical Center

Phone: 717-531-3834

Email: jlevenick@pennstatehealth.psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place