Status:
COMPLETED
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
Lead Sponsor:
Biokosmes Srl
Conditions:
Haemorrhoidal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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-...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06944951
Start Date
November 5 2024
End Date
January 17 2025
Last Update
April 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
C.M.I. Sisu Lucia Cristina
Craiova, Dolj, Romania