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RecruitingNCT07919080ExoskeletonEarUpdated Nov 5, 2026

Ergonomic Evaluation of Microscopic Ear Surgery With Exoskeleton: A Single Site Non-blinded Study

An observational study in Muskuloskeletan Pain, sponsored by East and North Hertfordshire NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by East and North Hertfordshire NHS Trust · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to learn whether an exoskeleton system can reduce musculoskeletal strain and pain during microscopic ear surgery in ENT surgeons performing tympanomastoid and related microscopic ear procedures. The main questions it aims to answer are:

Does the use of an exoskeleton reduce musculoskeletal strain (measured via surface EMG activity) during surgery? Does the use of an exoskeleton reduce subjective pain scores in the neck, back, and shoulders during surgery?

Researchers will compare surgeries performed with the exoskeleton versus surgeries performed without the exoskeleton to see if it reduces strain, muscle activity, and pain levels.

Participants will:

Perform microscopic ear surgeries with and without the exoskeleton system Wear surface EMG electrodes on the neck, back, and shoulders to record muscle activity Provide subjective pain/strain scores at regular intervals (every 5 minutes) during surgery Follow standard surgical preparation and positioning procedures before data collection begins

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Conditions studied

  • Muskuloskeletan Pain

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03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 1,252 observational studies indexed under Pain.

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Lead sponsor

East and North Hertfordshire NHS Trust is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population consists of ENT surgeons who routinely perform microscopic ear surgeries, including tympanomastoid procedures and hearing implant operations. Participants are clinicians working within the ENT department who are willing to undergo surface EMG monitoring and use the exoskeleton support system during live surgical procedures.

Eligible participants must have experience in microscopic ear surgery and no pre-existing musculoskeletal conditions that would limit their ability to perform surgery or safely use the exoskeleton.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ENT surgeons who perform a range of microscopic ear surgery including tympanomastoid surgery and hearing implants.
  • Willing to participate with surface EMG (sEMG) monitoring and utilise the Ottobock exoskeleton

Exclusion criteria

Exclusion Criteria:

  • Pre-existing musculoskeletal problems that limits procedures under microscope and tympanomastoid surgery
  • Unable to perform surgery using the exoskeleton
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • With Exoskeleton

    With Exoskeleton: ENT surgeons performing microscopic ear surgery while wearing the exoskeleton support system. During procedures, participants will have surface EMG electrodes placed on the neck, back, and shoulders to measure muscle activity, and will report subjective pain/strain scores at regular intervals.

  • Without Exoskeleton

    Without Exoskeleton: ENT surgeons performing microscopic ear surgery under standard conditions without the exoskeleton. The same protocol will be followed, including surface EMG monitoring and regular subjective pain/strain assessments, to allow comparison with the intervention group.

06

What researchers measure

Primary outcomes

  1. Change in Visual Analogue Scale (VAS) Score for Musculoskeletal Strain

    Difference in participant-reported musculoskeletal strain during microscopic tympanomastoid surgery performed with and without the exoskeleton. Strain will be assessed using a Visual Analogue Scale (VAS) at 5-minute intervals throughout each operation.

    Time frame: From the start of each operation to the end of the surgical procedure, with assessments every 5 minutes

  2. Difference in Surface Electromyography (sEMG) Amplitude (% Change From Rest)

    Difference in muscle activity, measured using surface electromyography (sEMG), during microscopic tympanomastoid surgery performed with and without the exoskeleton. Results will be expressed as percentage change from resting sEMG amplitude in the neck, shoulder and back muscles.

    Time frame: From the start of each operation to the end of the surgical procedure.

  3. Difference in Maximum Surface Electromyography (sEMG) Amplitude

    Difference in maximum muscle activity, measured using surface electromyography (sEMG), during microscopic tympanomastoid surgery performed with and without the exoskeleton. Maximum sEMG amplitude will be assessed in the neck, shoulder and back muscles

    Time frame: From the start of each operation to the end of the surgical procedure.

07

Study locations

1 of 1 sites recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2026
First posted
Nov 5, 2026
StartActual
Sep 24, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07919080
Lead sponsor
East and North Hertfordshire NHS Trust
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Sep 24, 2026
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Ananth Vijendren, BM, FRCS (ORL-HNS), PhD
Contact
Ananth.vijendren1@nhs.net
+441438288019
Toral Odedra
Contact
toral.odedra@nhs.net
Ananth Vijendren
principal investigator · East and North Hertfordshire Teaching NHS Trust

Oversight

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

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