N/A
N=50
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze® PLUS
Haemorrhoidal Disease
Bottom Line
View on ClinicalTrials.gov: NCT06944951 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD) — 14.04; 7.80 Score — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrophilic emulsion for the relief of haemorroidal symptoms (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biokosmes Srl
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Performance by the Improvement in the Quality of Life Measured Through the Score on The Short Health Scale for Haemorrhoidal Disease (SHSHD) |
14.04; 7.80 | < 0.0001 sig |
| SECONDARY Assessment of Performance Through the Score on Haemorrhoid Severity Score (HSS) Reported by Physician |
8.50; 6.48 | < 0.0001 sig |
| SECONDARY Assessment of Performance Through the Score Haemorrhoidal Disease Symptom Score (HDSS) Reported by Patient |
10.12; 7.20 | < 0.0001 sig |
| SECONDARY Number of Treatment-emergent Adverse Events |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT06944951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.