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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06860048




Registration number
NCT06860048
Ethics application status
Date submitted
25/02/2025
Date registered
5/03/2025

Titles & IDs
Public title
Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery
Scientific title
Randomized Controlled Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery
Secondary ID [1] 0 0
2022/ETH02203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ergonomics 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Arm sleeve

Active comparator: Arm sleeve - Randomised to wear arm sleeve on left or right


Treatment: Devices: Arm sleeve
Randomised to wear arm sleeve on left or right
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Muscle fatigue
Timepoint [1] 0 0
2 hours after intervention

Eligibility
Key inclusion criteria
* Robotic surgeon
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2024
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Department of Surgery, Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Government body
Name
Prince of Wales Hospital, Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06860048