Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand

January 24, 2023 updated by: Waldfriede Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (pre-surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI measure of 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 MRI in compare to pre-surgery ultrasonography
Baseline (pre-surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Waldfriede Hospital

Investigators

  • Study Chair: Martin Lautenbach, MD, Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
  • Principal Investigator: Markus Bock, MD, Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2020

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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