Granuloma, PyogenicNCT05692427
Evaluation of Cryotherapy in Granuloma Pyogenicum
A study testing Cryopen - Cryotherapy in people with Granuloma, Pyogenic and Cryotherapy Effect, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Granuloma, Pyogenic, Cryotherapy Effect
- What is being tested?
- Cryopen - Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- diagnosis of granuloma pyogenicum
Who cannot join
- no approvement of cryotherapy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8036
Christina Flucher, Dr.med.univ, 004331638580028, christina.flucher@medunigraz.at
About this study
Official title: Evaluation of Cryotherapy in Granuloma Pyogenicum by Means of Cryopen Compared to Surgical Removal
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.
- Conditions
- Granuloma, Pyogenic, Cryotherapy Effect
- Being tested
- Cryopen - Cryotherapy
- Medical subject headings
- Granuloma, Pyogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopen - CryotherapyDevice
Cryotherapy with N20
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Other | Cryotherapy on granuloma pyogenicum Receives: Device: Cryopen - Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Granuloma pyogenicum
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granuloma, PyogenicStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692427
- Sponsor's protocol ID
- 34-028 ex 21/22
- Status last verified
- Mar 2024
- First submitted
- 11 Jan 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cryotherapy in Granuloma Pyogenicum by Means of Cryopen Compared to Surgical Removal
- ClinicalTrials.gov ID
- NCT05692427
- Acronym / sponsor ID
- 34-028 ex 21/22
- Conditions
- Granuloma, Pyogenic, Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Other | Device: Cryopen - CryotherapyCryotherapy on granuloma pyogenicum |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- diagnosis of granuloma pyogenicum
Key exclusion criteria (1 listed)
- no approvement of cryotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopen - CryotherapyCryotherapy with N20 | Device | Cryotherapy |
Primary outcome
Recurrence of Granuloma pyogenicum
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryopen - Cryotherapy in people with Granuloma, Pyogenic and Cryotherapy Effect, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Granuloma pyogenicum (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.