New device for treating hemorrhoids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.