Trials / Completed
CompletedNCT03833076
A New Class IIb MD in Proctological Disorders
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- Nathura S.p.A · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-08-22
- Primary completion
- 2020-11-27
- Completion
- 2020-11-27
- First posted
- 2019-02-06
- Last updated
- 2020-12-23
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03833076. Inclusion in this directory is not an endorsement.