New Local Treatment of Radiation-induced Proctitis
NCT05489107 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2022-08-05
Summary
A prospective single-center observational study to evaluate the effectiveness of a local treatment with a mixture of hyaluronic acid, chondroitin sulfate and poloxamer 407 in patients with radiation-induced proctitis.
Conditions
- Radiation Proctitis
Interventions
- OTHER
-
Ziverel
Within a first flexible rectoscopy (Day 1) the product will be applied transanally. Then the patients will apply it as enemas twice daily for 7 days. On day 8 (after treatment completion), and on day 31 (after 23 days of no treatment) follow-up flexible rectoscopies will be performed.
Sponsors & Collaborators
-
Barmherzige Brüder Vienna
lead OTHER
Principal Investigators
-
Bernhard Dauser, Assoc. Prof. · Krankenhaus der Barmherzige Brüder Wien
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2023-07-01
- Completion
- 2023-07-31
Countries
- Austria
Study Locations
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