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
Developeration AB
35 participants
Jun 15, 2023
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
Inclusion Criteria3
- Adult
- Hemorrhoidal disease grade II and III
- American Society of Anesthesiologists (ASA) classification I-III.
Exclusion Criteria15
- Previous surgical treatment for hemorrhoids by all methods except rubber band ligation or sclerosing injection therapy within the last 3 years.
- Previous surgical treatment with rubber band ligation or injection therapy within the last 2 months.
- More than three surgical treatments with rubber band ligation or sclerosing injection therapy within the last 3 years.
- Under medication with immunosuppressive drugs and/or anticoagulant drugs (not including 75mg acetylsalicylic acid) and not able to interrupt the anticoagulant drug medication or replace it with low molecular weight heparin for 5 days.
- Have ulcerative colitis, Crohn's disease or other intestinal inflammatory disease or presence of inflamed or thickened mucosa of the rectum.
- Presence of anal fissure, anal stenosis, stricture, fistulas or ulcers in the rectal area.
- The rectum has not been prepared prior to the investigation with rectal enema and is contaminated with feces that cannot easily be removed.
- Have schizophrenia, untreated depression or other mental illness or conditions that may affect judgment, sensation of pain or inability to complete the follow-up.
- Under medication of morphine or other strong painkillers, not including paracetamol.
- Fecal incontinence (not including soiling due to hemorrhoidal disease), or conditions with impaired sensation in the rectal area or impaired function of the anal sphincter.
- Previous rectal radiation.
- Rectal cancer or previous surgery due to rectal cancer.
- Pregnancy
- Hypercoagulability disorders or diseases that result in increased risk of bleeding.
- Impaired immune system or condition that increases the risk of infection.
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05782010