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Status unknownNCT04416828Updated Jan 26, 2023

Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand

An observational study in Ganglion Cyst of Both Hands, sponsored by Waldfriede Hospital. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.

Sponsored by Waldfriede Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ganglion Cyst of Both Hands

Keywords

  • Portable ultrasound
  • Diagnostics
  • Mobile ultrasound
  • Hand held ultrasound
  • Wireless ultrasound
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DevicePortable wireless ultrasonography devices

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

  • DeviceCart-based ultrasonography device

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

05

What researchers measure

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

    Time frame: 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

    Time frame: Baseline (pre-surgery)

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04416828
Lead sponsor
Waldfriede Hospital
Responsible party
Sponsor
First posted
Jun 4, 2020
Start date
Jun 4, 2020
Primary completion
May 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jan 26, 2023

Study contacts

Nike Kortum
Contact
handchirurgie@waldfriede.de
00493081810201
Markus Bock, MD
Contact
m.bock@waldfriede.de
00493081810201
Martin Lautenbach, MD
study chair · Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
Markus Bock, MD
principal investigator · Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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