Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device PROCTOeze® PLUS in the Relief of Haemorrhoidal Disease and Anal Irritation Symptoms

NCT ID: NCT06944951

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2025-01-17

Brief Summary

This trial aims to evaluate the overall performance and safety of the MD PROCTOeze® PLUS in relieving symptomatology of haemorrhoidal disease and anal irritation in adult patients affected by Grade I-II (Goligher classification) haemorrhoids as assessed by the patient and the Investigator at the end of the treatment period.

Detailed Description

The protocol is based on what is already known on both the topic object of the study, i.e., the symptomatic treatment of haemorrhoids, and the investigational medical device - PROCTOeze® PLUS - which is a specific adjuvant for the symptomatic relief of internal and external haemorrhoids and anal irritation. Due to its formulation, it contributes to the physiological restoration of the anal and perianal tissues.

The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyse, the data needed to study the relationships between different variables.

Conditions

Haemorrhoidal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PROCTOeze® PLUS

Administration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology.

Group Type: EXPERIMENTAL

Hydrophilic emulsion for the relief of haemorroidal symptoms

Intervention Type: DEVICE

Administration for 2 weeks of PROCTOeze® PLUS - a soft and light hydrophilic emulsion able to provide symptomatic relief of haemorrhoids and anal irritation.

Interventions

Hydrophilic emulsion for the relief of haemorroidal symptoms

Administration for 2 weeks of PROCTOeze® PLUS - a soft and light hydrophilic emulsion able to provide symptomatic relief of haemorrhoids and anal irritation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men and women ≥ 18 years old.
• Patients diagnosed with Grade I - II symptomatic haemorrhoids (according to Goligher classification) confirmed by clinical and anoscopic or proctoscopic examination performed within 3 months before baseline.
• Patients able to do self-administration at home of the MD, for 14 days, to treat symptoms of haemorrhoids and anal irritation.
• Patient free from the following treatments for haemorrhoids for at least 4 weeks: laser treatments for haemorrhoids, steroidal or non-steroidal anti-inflammatory drugs, analgesics, any anti-haemorrhoidal treatment, anticoagulants, and antiplatelet agents.
• Patients able to communicate adequately with the Investigator and understand the tral questionnaire.
• Patients able to understand and who can provide valid informed consent to the trial.

Exclusion Criteria

• Inflammatory and infectious disease of the digestive tract (e.g., IBD - Inflammatory Bowel Disease).
• Frequent hemorraidal bleeding
• Severe, uncontrolled hypertension, renal failure, cirrhosis, colorectal cancer, anal fissure or fistula.
• Patients with known sensitivity to the tested medical device or its components.
• Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study.
• Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biokosmes Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

C.M.I. Sisu Lucia Cristina

Craiova, Dolj, Romania

Countries

Romania

Other Identifiers

OpBio/0123/MD

Identifier Type: -

Identifier Source: org_study_id