Study of PexyEazy Device for Treating Grade II and III Hemorrhoids in Adults

What this Trial Is About

This research aims to assess the safety and performance of PexyEazy, a new device designed to treat grade II and III hemorrhoids using the mucopexy method. Hemorrhoidal disease occurs when hemorrhoidal cushions slide down in the anal canal, causing symptoms like bleeding, leakage, itching, and pain. Traditional surgery for severe hemorrhoids often involves long recovery and complications, so this study explores a less invasive, semi-automatic approach that can be done on awake patients in under 10 minutes. The PexyEazy device folds the mucosa above the hemorrhoids and applies sutures using a semi-automatic system, lifting the hemorrhoids back to their normal position. This procedure improves venous drainage and reduces swelling. The device includes an examination proctoscope, handle with depth setting piston, light shuttle, mucopexy device with three operating areas, and a battery pack. The study involves 35 patients, with the first 6-10 undergoing the procedure under general anesthesia and the rest awake. Follow-ups occur after 1 week, 3 months, and 1 year. Participants will have clinical examinations, questionnaires on quality of life and hemorrhoid symptoms, and monitoring of pain, complications, and use of pain relief drugs at follow-up visits. The study measures surgical results, device validation, surgery duration, pain presence, anesthesia needs, and perioperative complications immediately after the procedure. Long-term outcomes include symptom changes, clinical outcomes, quality of life, and sick leave duration, documented up to one year after treatment.

SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids