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

NCT05782010 | Recruiting DMC

• 1 other identifier: CIV-23-01-041830
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemorrhoids; Hemorrhoids, Internal; Suture; Complications, Infection or Inflammation; Rectal Diseases; Gastrointestinal Diseases

Keywords

PexyEazy

Outcome Measures

Primary Outcomes (6)

• Surgical result

  Clinical evaluation that a proper mucopexy has been achieved above all three locations (3, 7 and 11 o'clock) and any signs of bleeding or other damage to the mucosa, which is documented by the surgeon and by photography.

  Directly after the surgical procedure

• Validation of device

  The handling and performance of the device is validated through a questionnaire that the surgeon fills out after the procedure.

  Directly after the surgical procedure.

• Registered duration of surgery

  Duration of surgery (minutes)

  Directly after the surgical procedure.

• Presence of pain

  The patient fill in a questionnaire with a scale between 1 and 10, where 1 is no pain and 10 is the worst possible pain.

  Directly after the surgical procedure.

• Need of anesthesia, pain relief or local anesthesia

  The need for per-operative anesthesia and/or sedation and/or pain relied (morphine) and/or local anesthesia will be registered.

  Directly after the surgical procedure.

• Per-operative complications

  Adverse events (both complication and device malfunction) during or directly after the procedure, which will be registered by a questionnaires filled in by patient and surgeon.

  Directly after the surgical procedure.

Secondary Outcomes (7)

• Use of pain relief drugs after surgery

  1 week, 3 months and 1 year after surgery

• Pain after surgery

  1 week, 3 months and 1 year after surgery

• Post operative complications

  1 week, 3 months and 1 year after surgery

• Clinical outcome

  3 months and 1 year after surgery

• Change of symptoms

  Before the procedure, 1 week, 3 months and 1 year after the procedure.

Other Outcomes (1)

• Cost

  3 month and 1 year

Study Arms (1)

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.

Device: PexyEazy

Interventions

PexyEazy DEVICE

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.

PexyEazy procedure

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Hemorrhoidal disease grade II and III
• American Society of Anesthesiologists (ASA) classification I-III.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Developeration AB: lead

Study Sites (3)

Frölunda Specialistsjukhus

Frölunda, 42144, Sweden

RECRUITING

Norrtälje Sjukhus

Norrtälje, 76129, Sweden

RECRUITING

Capio kirurgkliniken, Sophiahemmet

Stockholm, 11486, Sweden

NOT YET RECRUITING

Related Publications (3)

• Aigner F, Gruber H, Conrad F, Eder J, Wedel T, Zelger B, Engelhardt V, Lametschwandtner A, Wienert V, Bohler U, Margreiter R, Fritsch H. Revised morphology and hemodynamics of the anorectal vascular plexus: impact on the course of hemorrhoidal disease. Int J Colorectal Dis. 2009 Jan;24(1):105-13. doi: 10.1007/s00384-008-0572-3. Epub 2008 Sep 3.

  PMID: 18766355 RESULT

• Aigner F, Kronberger I, Oberwalder M, Loizides A, Ulmer H, Gruber L, Pratschke J, Peer S, Gruber H. 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. Colorectal Dis. 2016 Jul;18(7):710-6. doi: 10.1111/codi.13280.

  PMID: 26787597 RESULT

• Gupta PJ, Kalaskar S, Taori S, Heda PS. Doppler-guided hemorrhoidal artery ligation does not offer any advantage over suture ligation of grade 3 symptomatic hemorrhoids. Tech Coloproctol. 2011 Dec;15(4):439-44. doi: 10.1007/s10151-011-0780-7. Epub 2011 Oct 28.

  PMID: 22033542 RESULT

MeSH Terms

Conditions

Hemorrhoids; Infections; Inflammation; Rectal Diseases; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Kressner, Dr

  Norrtälje Sjukhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Ungerstedt, Dr

CONTACT

+46709427842; johan.ungerstedt@developeration.se

Ulf Kressner, Dr

CONTACT

ulfkressner@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: March 23, 2023
• Study Start: June 15, 2023
• Primary Completion: April 28, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: From the start of the study to the end of the study.
• Access Criteria: E-mail to office@developeration.se for requesting information.

Locations

SE (3)