SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids

Launched by DEVELOPERATION AB · Mar 22, 2023

Keywords

ClinConnect Summary

The SCI-Pex study is looking at the safety and effectiveness of a new device called PexyEazy®, which is designed to treat hemorrhoids using a method called mucopexy. This method involves gently lifting the hemorrhoids back to their normal position to help reduce swelling and symptoms. PexyEazy® aims to make this process quicker and easier, allowing it to be done in less than 10 minutes while the patient is awake. The study will involve 35 patients who have grade II and III hemorrhoids, and participants will be monitored for any side effects, pain levels, and overall quality of life for up to five years after the procedure.

To be eligible for the study, participants need to be adults with specific types of hemorrhoids and should not have had recent surgical treatments for their condition. They also need to be in good overall health without certain medical issues that could complicate the treatment. If you join the trial, you can expect to receive the PexyEazy® treatment and follow-up appointments to check on your recovery and any changes in your symptoms. This trial is an opportunity to help improve treatment options for hemorrhoids while also contributing to medical research.

Gender

ALL

Eligibility 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.