Actively Recruiting
SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
Led by Developeration AB · Updated on 2025-03-07
35
Participants Needed
3
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult
- Hemorrhoidal disease grade II and III
- American Society of Anesthesiologists (ASA) classification I-III.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Frölunda Specialistsjukhus
Frölunda, Sweden, 42144
Actively Recruiting
2
Norrtälje Sjukhus
Norrtälje, Sweden, 76129
Actively Recruiting
3
Capio kirurgkliniken, Sophiahemmet
Stockholm, Sweden, 11486
Not Yet Recruiting
Research Team
J
Johan Ungerstedt, Dr
CONTACT
U
Ulf Kressner, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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