Ganglion Cyst of Both HandsNCT04416828
Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand
An observational study of Ganglion Cyst of Both Hands, run by Waldfriede Hospital at 1 site in Germany.
Trial summary
The aim of this study is to investigate if inexpensive, readily available and portable wireless ultrasound devices can detect ganglion cysts of the wrist and hand in compare to a cart-based ultrasound device before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ganglion Cyst of Both Hands
- What is being tested?
- Portable wireless ultrasonography devices and Cart-based ultrasonography device
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jun 2020to 31 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ninety male and female patients with ganglion cyst of the wrist or hand planned for surgery will be recruited at the hand surgery outpatient clinic of the Waldfriede Hospital Berlin. Patients will be diagnosed with ganglion cyst of the hand/wrist by an experienced hand surgeon using clinical and MRI data.
Who may be able to join
- Flexor tendon sheath ganglion cyst
- Dorsal ganglion cyst
- Palmar ganglion cyst
- Male and female patients minimum age 18 years
- MRI of the affected area
Who cannot join
- Pregnancy, lactation
- Malignant disease
- Insufficient mental possibility of cooperation
- Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Waldfriede Hospital
Berlin, 14163
Markus Bock, Dr. med., 00493081810201, m.bock@waldfriede.de
Martin Lautenbach, Dr. med., 00493081810201, m.lautenbach@waldfriede.de
About this study
The aim of this study is to investigate if inexpensive, readily available and portable wireless ultrasound devices can detect ganglion cysts of the wrist and hand in compare to a cart-based ultrasound device before surgery.
- Conditions
- Ganglion Cyst of Both Hands
- Being tested
- Portable wireless ultrasonography devices, Cart-based ultrasonography device
- Keywords
- Portable ultrasound, Diagnostics, Mobile ultrasound, Hand held ultrasound, Wireless ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable wireless ultrasonography devicesDevice
Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging
Cart-based ultrasonography deviceDevice
Patients with suspected ganglion cyst of the wrist or hand receive conventional cart-based ultrasound imaging
| Study group | Role | What they receive |
|---|---|---|
| Suspected ganglion cyst of the wrist or hand | Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging AND cart-based ultrasound imaging before surgery. Receives: Device: Portable wireless ultrasonography devices; Device: Cart-based ultrasonography device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size and location of ganglion cysts of the wrist and hand
Assessment of size in cm and location of the ganglion cyst of the wrist or hand by pre-surgery wireless ultrasound in compare to pre-surgery cart-based ultrasound
Measured: Baseline (pre-surgery)
Secondary outcomes (1)
MRI measure of size and location of ganglion cysts of the wrist and hand
Assessment of size in cm and location of the ganglion cyst of the wrist or hand by pre-surgery MRI in compare to pre-surgery ultrasonography
Measured: Baseline (pre-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start4 Jun 2020
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ganglion Cyst of Both HandsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waldfriede Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Lautenbach, MD, Study chair, Hospital Waldfriede, Argentinische Allee 40, 14163 BerlinMarkus Bock, MD, Principal investigator, Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416828
- Sponsor's protocol ID
- 2019.4
- Status last verified
- Jan 2023
- First submitted
- 29 May 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand
- ClinicalTrials.gov ID
- NCT04416828
- Acronym / sponsor ID
- 2019.4
- Conditions
- Ganglion Cyst of Both Hands
- Keywords
- Portable ultrasound, Diagnostics, Mobile ultrasound, Hand held ultrasound, Wireless ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Waldfriede HospitalUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Jun 2020 (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.
The aim of this study is to investigate if inexpensive, readily available and portable wireless ultrasound devices can detect ganglion cysts of the wrist and hand in compare to a cart-based ultrasound device before surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected ganglion cyst of the wrist or hand | – | Device: Portable wireless ultrasonography devices, Device: Cart-based ultrasonography devicePatients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging AND cart-based ultrasound imaging before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ninety male and female patients with ganglion cyst of the wrist or hand planned for surgery will be recruited at the hand surgery outpatient clinic of the Waldfriede Hospital Berlin. Patients will be diagnosed with ganglion cyst of the hand/wrist by an experienced hand surgeon using clinical and MRI data.
Key inclusion criteria (5 listed)
- Flexor tendon sheath ganglion cyst
- Dorsal ganglion cyst
- Palmar ganglion cyst
- Male and female patients minimum age 18 years
- MRI of the affected area
Key exclusion criteria (4 listed)
- Pregnancy, lactation
- Malignant disease
- Insufficient mental possibility of cooperation
- Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
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 |
|---|---|---|
| Portable wireless ultrasonography devicesPatients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging | Device | Suspected ganglion cyst of the wrist or hand |
| Cart-based ultrasonography devicePatients with suspected ganglion cyst of the wrist or hand receive conventional cart-based ultrasound imaging | Device | Suspected ganglion cyst of the wrist or hand |
Primary outcome
Size and location of ganglion cysts of the wrist and hand
Time frame: Baseline (pre-surgery)
Assessment of size in cm and location of the ganglion cyst of the wrist or hand by pre-surgery wireless ultrasound in compare to pre-surgery cart-based ultrasound
1 secondary outcome
MRI measure of size and location of ganglion cysts of the wrist and hand
Time frame: Baseline (pre-surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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.
Martin Lautenbach, MD study chair
Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
Markus Bock, MD principal investigator
Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ganglion Cyst of Both Hands, run by Waldfriede Hospital at 1 site in Germany.
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 5 inclusion and 4 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 26 Jan 2023. 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 Germany. 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?
Contact Nike Kortum (00493081810201, handchirurgie@waldfriede.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size and location of ganglion cysts of the wrist and hand (time frame: Baseline (pre-surgery)). 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 26 Jan 2023.