Trial Outcomes & Findings for Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze® PLUS (NCT NCT06944951)

Start of enrolment (FPI) 5th November 2024; End of enrolment (LPI) 17th December 2024; End of treatment (LPO) 17th January 2025. Recruitment in the ambulatory of a General Physician office.

Race and Ethnicity were not collected from any participant.

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.

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".

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".

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.