Clinical trial NCT06944951: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemorrhoidal Disease
Keywords: haemorroidal disease
haemorroidal crisis
internal haemorroids
external haemorroids
anal irritation
Lead sponsor: Biokosmes Srl
Sponsor class: INDUSTRY
First posted: 2025-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Assessment of performance by the improvement in the quality of life
timeFrame: From enrollment to the end of treatment on day 14.
Secondary outcomes:
measure: Assessment of performance through Haemorrhoid Severity Score (HSS) reported by physician
timeFrame: From enrollment to the end of treatment on day 14.
measure: Assessment of performance through Haemorrhoidal Disease Symptom Score (HDSS) reported by patient
timeFrame: From enrollment to the end of treatment on day 14.
measure: Medical device safety evaluation through incidence of treatment-emergent adverse events
timeFrame: From enrollment to the end of study on day 30.
Other outcomes:
Locations:
city: Craiova
country: Romania
facility: C.M.I. Sisu Lucia Cristina
state: Dolj
Study officials:
References: