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

NCT06944951 | Completed Results

• 1 other identifier: OpBio/0123/MD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemorrhoidal Disease

Keywords

haemorroidal disease; haemorroidal crisis; internal haemorroids; external haemorroids; anal irritation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of Performance Through the Score on Haemorrhoid Severity Score (HSS) Reported by Physician

  From enrollment to the end of treatment on day 14.

• Assessment of Performance Through the Score Haemorrhoidal Disease Symptom Score (HDSS) Reported by Patient

  From enrollment to the end of treatment on day 14.

• Number of Treatment-emergent Adverse Events

  From enrollment to the end of study on day 30.

Study Arms (1)

PROCTOeze® PLUS

EXPERIMENTAL

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

Device: Hydrophilic emulsion for the relief of haemorroidal symptoms

Interventions

Hydrophilic emulsion for the relief of haemorroidal symptoms DEVICE

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

PROCTOeze® PLUS

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biokosmes Srl: lead

Study Sites (1)

C.M.I. Sisu Lucia Cristina

Craiova, Dolj, Romania

Location

Limitations and Caveats

This study has no limitations since there are no drop-out patients and the symptoms measurements were performed with objective, widely-accepted and validated scales. In addition, treatment compliance was optimal according to the patient diary, which was filled in daily during the treatment period by all participants.

Results Point of Contact

• Title: Donatella Mariani
• Organization: Biokosmes Srl

d.mariani@solarishc.ch

+41 79 844 2600

Study Officials

• Lucia Cristina Sisu, Dr.

  CMI Dr Sisu Lucia Cristina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: November 5, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)