Evaluation of Cryotherapy in Granuloma Pyogenicum
Primary Purpose
Granuloma, Pyogenic, Cryotherapy Effect
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cryopen - Cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Granuloma, Pyogenic
Eligibility Criteria
Inclusion Criteria: diagnosis of granuloma pyogenicum Exclusion Criteria: no approvement of cryotherapy
Sites / Locations
- Medical University of GrazRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cryotherapy
Arm Description
Cryotherapy on granuloma pyogenicum
Outcomes
Primary Outcome Measures
Recurrence of Granuloma pyogenicum
Secondary Outcome Measures
Full Information
NCT ID
NCT05692427
First Posted
January 11, 2023
Last Updated
January 11, 2023
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT05692427
Brief Title
Evaluation of Cryotherapy in Granuloma Pyogenicum
Official Title
Evaluation of Cryotherapy in Granuloma Pyogenicum by Means of Cryopen Compared to Surgical Removal
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Surgical excision needs general anesthesia and might have complications due to anesthesia. Cryotherapy can be used in an outpatient setting and doesn't need general anesthesia.
This study will evaluate if cryotherapy works in granuloma pyogenicum with the advancement of no general anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Granuloma, Pyogenic, Cryotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryotherapy
Arm Type
Other
Arm Description
Cryotherapy on granuloma pyogenicum
Intervention Type
Device
Intervention Name(s)
Cryopen - Cryotherapy
Intervention Description
Cryotherapy with N20
Primary Outcome Measure Information:
Title
Recurrence of Granuloma pyogenicum
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosis of granuloma pyogenicum
Exclusion Criteria:
no approvement of cryotherapy
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Flucher, Dr.med.univ
Phone
004331638580028
Email
christina.flucher@medunigraz.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Cryotherapy in Granuloma Pyogenicum
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