Evaluation of Performance and Safety of a New Medical Device Class IIb Not Yet CE Marked in Proctological Disorders: a Randomised, Double-blind, Parallel-groups, Multicentric, Placebo-controlled, Prospective Clinical Study.

Nathura S.p.A1 site in 1 country118 target enrollmentAugust 22, 2019

ConditionsProctological Disorders

Overview

Phase: N/A
Intervention: Not specified
Conditions: Proctological Disorders
Sponsor: Nathura S.p.A
Enrollment: 118
Locations: 1
Primary Endpoint: Assessment of symptoms according to the Proctological Symptom Scale (PSS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.

Registry

clinicaltrials.gov

Start Date

August 22, 2019

End Date

November 27, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nathura S.p.A

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients of both sexes aged between 18 and 75 years.
•Patients reporting symptoms of haemorrhoids (grade 1-3\*), anal fissures and proctitides or already diagnosed with haemorrhoids (grade 1-3), anal fissures and proctitides; diagnosis confirmed by proctological examination at Screening Visit.
•\*Grade 1 - Haemorrhoid protrudes into the anal canal but does not prolapse outside the anus.
•Grade 2 - Haemorrhoid protrudes through the anus during straining or evacuation but returns spontaneously.
•Grade 3 - Haemorrhoid protrudes through the anus during straining or evacuation but needs to be manually returned to position.
•Grade 4 - Haemorrhoid remains prolapsed outside of the anus.
•Patients agreeing not to use any other systemic or topic medicinal / product to treat haemorrhoids, anal fissures and proctitides during the study and not to modify their personal hygiene products.
•Female patients of childbearing potential following a reliable contraceptive method (according to Investigator's opinion).
•Willingness to participate in the study and to sign an informed consent form.

Exclusion Criteria

•Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
•Patients presenting complicated haemorrhoids.
•Patients with Crohn's disease or malignancy.
•Patients presenting undiagnosed abnormal rectal bleeding.
•Patients with known or suspected rectal hypersensitivity.
•Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
•Patients in treatment with topic or systemic medications / products to treat haemorrhoids, fissures and proctitides, currently or in the 2 weeks prior to Screening Visit.
•Patients using laxatives or stool softener currently or in the 2 weeks prior to Screening Visit.
•Patients pregnant or breastfeeding.
•Patients reporting past or present narcotic addiction or alcoholism.

Outcomes

Primary Outcomes

Assessment of symptoms according to the Proctological Symptom Scale (PSS)

Time Frame: from Day 0 to Day 14

Assessment of symptoms according to the Proctological Symptom Scale - PSS (according to 100 mm Visual Analogue Scales; from "no symptoms" to "overwhelming symptoms); comparison between groups, from Day 0 to Day 14