RecruitingNot ApplicableNCT05782010

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

SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids


Sponsor

Developeration AB

Enrollment

35 participants

Start Date

Jun 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called PexyEazy for people with gastrointestinal diseases, hemorrhoids, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 84 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPexyEazy

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

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NCT05782010


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