Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand

Ganglion Cyst of Both Hands Clinical Trial

Official title:

Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416828
• Other study ID #: 2019.4
• Status: Recruiting
• Start date: June 4, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Waldfriede Hospital
• Contact: Nike Kortum
• Phone: 00493081810201
• Email: handchirurgie[@]waldfriede.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Flexor tendon sheath ganglion cyst
• Dorsal ganglion cyst
• Palmar ganglion cyst
• Male and female patients minimum age 18 years
• MRI of the affected area

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cysts
• Ganglion Cyst of Both Hands
• Ganglion Cysts

Intervention

Device:
• Portable wireless ultrasonography devices
Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging
• Cart-based ultrasonography device
Patients with suspected ganglion cyst of the wrist or hand receive conventional cart-based ultrasound imaging

Locations

Country	Name	City	State
Germany	Waldfriede Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Waldfriede Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline (pre-surgery)
Secondary	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	Baseline (pre-surgery)