CompletedNot Applicable

EndoMaster EASE System for Treatment of Colorectal Lesions

Hong Kong45 participantsStarted 2020-05-01

Plain-language summary

This is a prospective, single arm study to assess the safety and performance of the EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients with colorectal neoplasms.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 and ≤ 85;
✓. Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.

Exclusion criteria

✕. Informed consent not available;
✕. Carcinoma of colon or rectum with known involvement beyond the submucosa;
✕. Evidence of distant spread of colon cancer;
✕. Presence of another active malignancy;
✕. Pregnancy;
✕. Patients considered unfit for general anaesthesia;
✕. The endoscopic platform cannot reach the target site;
✕. Current participation in another clinical research study.

What they're measuring

Complete (R0) resection

Timeframe: 30 days

Trial details

NCT IDNCT04196062

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Colonic Neoplasms trials