Clinical trials

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Condition / disease
Location
Status: Recruiting

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

The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method. Mucopexy is a well established method where sutures are applied above the hemorrhoids. When knots are tied, the hemorrhoids are lifted inwards to their normal position, which makes them swell down and symptoms disappears. PexyEazy® perform a mukopexy in a semiautomatic, faster and easier way on awake patient in less than 10 minutes. The SCI-Pex study will evaluate the safety and performance of PexyEazy on 35 patients with hemorrhoids grade II and III with a follow-up after 1 week, 3 months and 1 years. Adverse events, pain and other complications will be recorded, quality of life and hemorrhoid symptom questionnaires and clinical examination after 3 months and 1 year will be monitored to evaluate the result after a PexyEazy® procedure.

Participants needed: 35
Trial details
Age: 18-84Biological sex: AllType: InterventionalSponsor: Developeration ABUpdated: Mar 7, 2025Locations: 3
Eligibility criteria

Adult [+2]

Previous surgical treatment for hemorrhoids by all methods except rubber band li... [+14]