Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand

NCT04416828 | Unknown

• 1 other identifier: 2019.4
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ganglion Cyst of Both Hands

Keywords

Portable ultrasound; Diagnostics; Mobile ultrasound; Hand held ultrasound; Wireless ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• MRI measure of size and location of ganglion cysts of the wrist and hand

  Baseline (pre-surgery)

Study Arms (1)

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.

Device: Portable wireless ultrasonography devices; Device: Cart-based ultrasonography device

Interventions

Portable wireless ultrasonography devices DEVICE

Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging

Suspected ganglion cyst of the wrist or hand

Cart-based ultrasonography device DEVICE

Patients with suspected ganglion cyst of the wrist or hand receive conventional cart-based ultrasound imaging

Suspected ganglion cyst of the wrist or hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Waldfriede Hospital: lead

Study Sites (1)

Waldfriede Hospital

Berlin, 14163, Germany

RECRUITING

Study Officials

• Martin Lautenbach, MD

  Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

  STUDY CHAIR

• Markus Bock, MD

  Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nike Kortum

CONTACT

00493081810201; handchirurgie@waldfriede.de

Markus Bock, MD

CONTACT

00493081810201; m.bock@waldfriede.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: June 4, 2020
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)