SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
Recruiting
N/A
Interventional Study
Hemorrhoids
Hemorrhoids, Internal
Suture; Complications, Infection or Inflammation
Rectal Diseases
Gastrointestinal Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 84
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 35 (estimated)
- Sponsor
- Developeration AB · Industry
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About This Trial
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® perf…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult
* Hemorrhoidal disease grade II and III
* American Society of Anesthesiologists (ASA) classification I-III.
Exclusion Criteria:
* Previous surgical treatment for hemorrhoids by all methods except rubber band ligation or sclerosing injection therapy within the last 3 ye…
Contacts