NCT06944951

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Biokosmes Srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-05
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2025-04-25
• Last updated: 2026-02-05
• Results posted: 2026-02-05

Locations

1 site across 1 country: Romania