SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids

Developeration AB3 sites in 1 country35 target enrollmentStarted: June 15, 2023Last updated: March 7, 2025

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: Developeration AB
Enrollment: 35
Locations: 3
Primary Endpoint: Validation of device

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Detailed Description

Background:

The generally accepted theory of why hemorrhoidal disease (HD) occurs is that the hemorrhoidal cushions slid down in the anal canal (muco-anal prolapse), which allows them to swell up. This creates problems with bleeding, leakage (soiling), itching and pain.

Traditionally, severe HD is treated by surgical removal of the hemorrhoids, but the procedure is associated with long recovery time, pain and complications like stenosis and incontinence. Minimal invasive and hemorrhoid preserving surgery has gained popularity during the last two decades with new methods like Procedure for Prolapse and Hemorrhoids (PPH)/Stapled Anopexy and Transanal Hemorrhoidal Dearterialisation (THD)/Hemorrhoidal Artery Ligation and Recto Anal Repair (HAL/RAR). Several studies have shown, thought that mucopexy alone result in equally good result as THD/HAL-RAR. There are several ways to perform a mucopexy with different ways in how the sutures are applied and how many rows of sutures that are done.

Other available methods focus on tissue destruction, for example sclerosing injections, laser, radio ablation, or methods with applied electricity that induce heat. These methods make the hemorrhoids to swell down but does not treat the muco-anal prolapse that are present in grade II and III hemorrhoids.

PexyEazy® perform a mucopexy in a new, semi-automatic way with the benefit of reducing the cost and time of surgery and is estimated to be able to be conducted without the need of general anesthesia.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 84 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•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.

Arms & Interventions

PexyEazy procedure

Experimental

PexyEazy procedure on patients with hemorrhoidal disease grade II and III. The study is descriptive and non-comparable to evaluate the safety and performance of PexyEazy.

Intervention: PexyEazy (Device)