Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze® PLUS

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

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.

Study Overview

• Status: Completed
• Conditions: Haemorrhoidal Disease
• Intervention / Treatment: Device: Hydrophilic emulsion for the relief of haemorroidal symptoms

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Dolj
    • Craiova, Dolj, Romania
      • C.M.I. Sisu Lucia Cristina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROCTOeze® PLUS; Administration for 2 weeks of the MD PROCTOeze® PLUS to improve the haemorrhoidal symptomatology.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD)	The Short Health Scale for Haemorrhoidal Disease (SHSHD) will be used to evaluate the Quality of Life. The questionnaire will be completed by the patient at baseline and day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 7, where lower grades are better, with a total of 4 items on the scale (minimum score 4, maximum score 28). Is an instrument with just 1 question in each of its 4 dimensions, including symptom burden, functional status, disease-specific worries, and general well-being measured according to A 7-point Likert scale to be summed giving a total score ranging from 4 to 28. The total of the four dimensions has been analyzed. The unit of measure is "score". SHS was adapted for HD (Short Health Scale for Haemorrhoidal Disease - SHSHD) in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines; SHSHD has shown to be a reliable and responsive measure for HRQoL.	From enrollment to the end of treatment on day 14.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Performance Through the Score on Haemorrhoid Severity Score (HSS) Reported by Physician	HSS is a physician-reported measurement instrument based on PNR-Bleed classification. All four components in this classification system are graded into five grades ranging from 1 to 5. Grade 1 is the normal anal cushions and Grade 5 is the worst grade in a specific characteristic. HSS is the total score obtained by the sum of the numerical grades of all four characteristics of haemorrhoids in the PNR-Bleed classification. The minimum HSS score is 4 and the maximum score can be 20. The HSS score of a normal person without any signs and symptoms of haemorrhoids is 4. Calculation of the HSS helps in the quantification of the haemorrhoidal disease for further reference and is helpful in post-treatment patient follow-up to grade the response to treatment and to assess the effectiveness or failure of any particular treatment regimen for haemorrhoids. The total of the four dimensions has been analyzed. The unit of measure is "score".	From enrollment to the end of treatment on day 14.
Assessment of Performance Through the Score Haemorrhoidal Disease Symptom Score (HDSS) Reported by Patient	The Haemorrhoidal Disease Symptom Score (HDSS), a patient-reported outcome questionnaire, will be administered by Investigator to each patient at baseline and at day 14, at the end of the treatment with the MD. Grades on a scale from 1 to 5, where lower grades are better, with a total of 5 items on the questionnaire. The HDSS is a patient-reported measurement instrument. It comprises five items. Symptoms are assessed using the patient-reported frequency of the 5 symptoms, including pain, itching, bleeding, soiling, and prolapse. Patients are instructed to answer based on their experience during the previous period. Each symptom is graded on a 5-point scale (0 = never, 1 = less than once a month, 2 = less than once a week, 3 = 1-6 days per week, 4 = every day or always), giving a total score ranging from 0 to 20. The total of the four dimensions has been analyzed. The unit of measure is "score".	From enrollment to the end of treatment on day 14.
Number of Treatment-emergent Adverse Events	Safety and tolerability will be evaluated through the incidence of Adverse Event, Serious Adverse Event, Adverse Device Effect, Serious Adverse Device Effect, Anticipated Serious Adverse Device Effect, and Unanticipated Serious Adverse Device Effect assessed by Investigator and reported according to the current legislation for the whole study period. Device Deficiency will be also evaluated. The number of adverse events recorded will be evaluated to measure the safety of the MD.	From enrollment to the end of study on day 30.

Collaborators and Investigators

• Sponsor: Biokosmes Srl
• Investigators: Principal Investigator: Lucia Cristina Sisu, Dr., CMI Dr Sisu Lucia Cristina

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): January 17, 2025
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: haemorroidal disease; haemorroidal crisis; internal haemorroids; external haemorroids; anal irritation
• Other Study ID Numbers: OpBio/0123/MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No