Clinical trial · Interventional
Hybrid APC Assisted EMR for Large Colon Polyps
Hybrid APC Assisted EMR for Large Colon Polyps to Reduce Local Recurrence : A Prospective Data Collection Study
NCT03390907CI-TRIAL-00054922completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenoma | Colon Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid APC | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hybrid APC
- description
- Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.
- interventionNames
- Device: Hybrid APC
Primary outcomes (1)
- measure
- Percentage of Participants Having Complete Resection
- timeFrame
- 6 months post initial procedure
- description
- The primary outcome of interest will be the percentage of participants having complete resection at 6 months.
Secondary outcomes (1)
- measure
- Measure of Within 30 Days of Procedure Adverse Events ( Post-polypectomy Bleeding and Post-polypectomy Syndrome)
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.