New device for treating hemorrhoids
SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
This study is testing a new device called PexyEazy® to see if it can safely and effectively treat grade II and III hemorrhoids in patients while making recovery easier and faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | Developeration AB Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Frölunda and 2 other locations) |
| Trial ID | NCT05782010 on ClinicalTrials.gov |
What this trial studies
The SCI-Pex study evaluates the safety and performance of PexyEazy®, a semi-automatic device designed for the treatment of grade II and III hemorrhoids using the mucopexy method. This multicenter, prospective investigation involves 35 patients and aims to assess outcomes such as adverse events, pain levels, and quality of life through questionnaires and clinical examinations at various follow-up intervals. The procedure is performed on awake patients in under 10 minutes, potentially reducing recovery time compared to traditional surgical methods.
Who should consider this trial
Good fit: Ideal candidates are adults with grade II and III hemorrhoidal disease who are classified as ASA I-III.
Not a fit: Patients with a history of recent surgical treatments for hemorrhoids or those with certain gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a quicker, less painful treatment option for patients suffering from hemorrhoids.
How similar studies have performed: While traditional mucopexy methods have shown success, the semi-automatic approach of PexyEazy® is a novel intervention that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Frölunda and 2 other locations
- Frölunda Specialistsjukhus — Frölunda, Sweden (Recruiting)
- Norrtälje Sjukhus — Norrtälje, Sweden (Recruiting)
- Capio kirurgkliniken, Sophiahemmet — Stockholm, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Ulf Kressner, Dr — Norrtälje Sjukhus
- Study coordinator: Johan Ungerstedt, Dr
- Email: johan.ungerstedt@developeration.se
- Phone: +46709427842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.