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SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
Sponsor: Developeration AB
Summary
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.
Official title: SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
Key Details
Gender
All
Age Range
18 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2023-06-15
Completion Date
2026-05-30
Last Updated
2025-03-07
Healthy Volunteers
No
Conditions
Interventions
PexyEazy
PexyEazy procedure on patients with hemorrhoidal disease grade II and III. The study is descriptive and non-comparable to evaluate the safety and performance of PexyEazy.
Locations (3)
Frölunda Specialistsjukhus
Frölunda, Sweden
Norrtälje Sjukhus
Norrtälje, Sweden
Capio kirurgkliniken, Sophiahemmet
Stockholm, Sweden