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A New Class IIb MD in Proctological Disorders

NCT03833076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2020-12-23

No results posted yet for this study

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.

Conditions

  • Proctological Disorders

Interventions

DEVICE

Medical device Procto

Medical device Procto presents itself as a translucent green gel with a typical smell.

DEVICE

Matching placebo

IP placebo presents itself as a translucent green gel with a typical smell.

Sponsors & Collaborators

  • Evidilya S.r.l.

    collaborator INDUSTRY

  • Nathura S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2020-11-27
Completion
2020-11-27

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03833076 on ClinicalTrials.gov