Evaluation of Cryotherapy in Granuloma Pyogenicum

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05692427

Collaborator

(none)

200

Enrollment

Location

Arm

40.9

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Granuloma, Pyogenic Cryotherapy Effect	Device: Cryopen - Cryotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Cryotherapy in Granuloma Pyogenicum by Means of Cryopen Compared to Surgical Removal

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Cryotherapy Cryotherapy on granuloma pyogenicum	Device: Cryopen - Cryotherapy Cryotherapy with N20

Arm

Intervention/Treatment

Other: Cryotherapy

Cryotherapy on granuloma pyogenicum

Device: Cryopen - Cryotherapy

Cryotherapy with N20

Outcome Measures

Primary Outcome Measures

Recurrence of Granuloma pyogenicum [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

diagnosis of granuloma pyogenicum

Exclusion Criteria:

no approvement of cryotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz	Styria	Austria	8036

Sponsors and Collaborators

Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT05692427

Other Study ID Numbers:

34-028 ex 21/22

First Posted:

Jan 20, 2023

Last Update Posted:

Jan 20, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Granuloma

Granuloma, Pyogenic

Study Results

No Results Posted as of Jan 20, 2023