Revised morphology and hemodynamics of the anorectal vascular plexus: impact on the course of hemorrhoidal disease.
Felix Aigner, Hannes Gruber, Friedrich Conrad...
https://pubmed.ncbi.nlm.nih.gov/18766355Actively Recruiting
Phase Not Applicable
Age: 18Years - 84Years
All Genders
ID05782010
SCI-Pex Study to Evaluate Safety and Performance of PexyEazy®, a Device for Treatment of Grade II and III Hemorrhoids
Led by Developeration AB · Updated on 2025-03-07
35
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety and performance of PexyEazy®, a new device designed to treat grade II and III hemorrhoids using the mucopexy method. Hemorrhoidal disease occurs when hemorrhoidal cushions slide down in the anal canal, causing symptoms like bleeding, leakage, itching, and pain. Traditional surgery for severe hemorrhoids often involves long recovery and complications, so this study explores a less invasive, semi-automatic approach that can be done on awake patients in under 10 minutes. The PexyEazy® device folds the mucosa above the hemorrhoids and applies sutures using a semi-automatic system, lifting the hemorrhoids back to their normal position. This procedure improves venous drainage and reduces swelling. The device includes an examination proctoscope, handle with depth setting piston, light shuttle, mucopexy device with three operating areas, and a battery pack. The study involves 35 patients, with the first 6-10 undergoing the procedure under general anesthesia and the rest awake. Follow-ups occur after 1 week, 3 months, and 1 year. Participants will have clinical examinations, questionnaires on quality of life and hemorrhoid symptoms, and monitoring of pain, complications, and use of pain relief drugs at follow-up visits. The study measures surgical results, device validation, surgery duration, pain presence, anesthesia needs, and perioperative complications immediately after the procedure. Long-term outcomes include symptom changes, clinical outcomes, quality of life, and sick leave duration, documented up to one year after treatment.
CONDITIONS
Brief Title
SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
Who Can Participate
Age: 18Years - 84Years
All Genders
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 or replace anticoagulant medication for 5 days
- Have ulcerative colitis, Crohn's disease, or other intestinal inflammatory disease or inflamed/thickened rectal mucosa
- Presence of anal fissure, anal stenosis, stricture, fistulas, or ulcers in the rectal area
- Rectum not prepared with enema and contaminated with feces that cannot be removed
- Schizophrenia, untreated depression, or other mental illness affecting judgment, pain sensation, or follow-up ability
- Under medication of morphine or other strong painkillers (excluding paracetamol)
- Fecal incontinence (excluding soiling due to hemorrhoidal disease) or impaired rectal sensation or anal sphincter function
- Previous rectal radiation
- Rectal cancer or previous rectal cancer surgery
- Pregnancy
- Hypercoagulability disorders or diseases increasing bleeding risk
- Impaired immune system or conditions increasing infection risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single surgical procedure
Participants undergo the PexyEazy procedure, a minimally invasive device treatment for grade II and III hemorrhoids, performed either under general anesthesia initially or on awake patients, to lift and fixate hemorrhoids internally.
1 visit (in-person)
Follow-up
Duration - 1 year
Participants are followed to assess surgical results, pain, complications, symptom changes, quality of life, and recovery over the course of one year after the procedure.
Visits at 1 week, 3 months, and 1 year after surgery
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
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Research Team
J
Johan Ungerstedt, Dr
U
Ulf Kressner, Dr
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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Published Research Related To This Trial
Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial.
F Aigner, I Kronberger, M Oberwalder...
https://pubmed.ncbi.nlm.nih.gov/26787597Doppler-guided hemorrhoidal artery ligation does not offer any advantage over suture ligation of grade 3 symptomatic hemorrhoids.
P J Gupta, S Kalaskar, S Taori...
https://pubmed.ncbi.nlm.nih.gov/22033542