Ergonomic Evaluation of Exoskeleton Use in Transoral, Endoscopic, and Transcervical ENT Surgery: A Single Site Non-blinded Study

NCT07855159 | Recruiting

• 1 other identifier: RD2026-23
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn whether the use of an exoskeleton system can reduce musculoskeletal strain and fatigue during ENT surgical procedures in ENT surgeons performing transoral, endoscopic, and transcervical operations. The main questions it aims to answer are: Does the use of an exoskeleton reduce musculoskeletal strain and muscle activity (measured via sEMG and MVC) during surgery? Does the use of an exoskeleton reduce subjective pain and fatigue in the neck, shoulders, and wrists during and after surgery? Researchers will compare surgeries performed with the exoskeleton to those performed without it to determine if the device reduces physical strain and improves ergonomic outcomes. Participants will: Perform ENT surgical procedures with and without the exoskeleton system Have surface EMG electrodes placed on the neck and shoulders to measure muscle activity Undergo maximum voluntary contraction (MVC) testing before and after surgery (including wrist assessments) Provide subjective pain/strain scores at regular intervals (every 10 minutes) during procedures Follow standard surgical preparation and positioning protocols while data are recorded throughout the operation

Conditions

Muskuloskeletan Pain

Outcome Measures

Primary Outcomes (1)

• • Differences in VAS and motor unit firing (via sEMG) of participants with and without the exoskeleton during transoral, endoscopic and transcervical ENT surgery. • Change in motor unit firing during MVC comparing before and after the surgical procedure.

  From the start of each surgery (initiation of sEMG recording) to the end of the surgical procedure, with subjective measurements recorded every 10 minutes throughout the operation.

Study Arms (2)

With Exoskeleton

With Exoskeleton: ENT surgeons performing transoral, endoscopic, or transcervical ENT surgical procedures while wearing the exoskeleton support system. Participants will undergo surface EMG (sEMG) monitoring of the neck and shoulder muscles during surgery, along with maximum voluntary contraction (MVC) measurements taken before and after the procedure (including wrist assessments). Subjective pain and fatigue scores will be recorded at regular intervals (every 10 minutes) throughout the operation.

Without Exoskeleton

Without Exoskeleton: ENT surgeons performing the same types of surgical procedures under standard conditions without the exoskeleton. The identical protocol will be followed, including sEMG monitoring, pre- and post-operative MVC measurements, and regular subjective pain and fatigue assessments, to allow direct comparison with the intervention group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of ENT surgeons who perform transoral, endoscopic, and/or transcervical ENT surgical procedures. Participants are clinicians within the ENT department who are experienced in these surgical techniques and have prior familiarity with the exoskeleton system. Eligible participants must be willing to undergo surface EMG (sEMG) monitoring and maximum voluntary contraction (MVC) testing, and to use the exoskeleton during live surgical procedures. Surgeons with pre-existing musculoskeletal conditions that limit their ability to perform surgery or safely use the exoskeleton are excluded.

You may qualify if:

• ENT surgeons who perform a range of transoral, endoscopic and/or transcervical ENT operations.
• Willing to participate with surface EMG (sEMG) monitoring and utilise the Ottobock exoskeleton.
• Prior familiarisation with the Ottobock exoskeleton, evidenced by completion of at least five (5) documented surgical procedures using the device before enrolment in the study.

You may not qualify if:

• Pre-existing musculoskeletal problems that limits transoral, endoscopic and/or transcervical ENT operations
• Inability to safely or effectively perform surgery using the Ottobock exoskeleton.
• Lack of prior familiarisation with the Ottobock exoskeleton, defined as failure to complete at least five (5) documented surgical procedures using the device prior to enrolment in the study.

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Study Sites (1)

Lister Hospital, East and North Hertfordshire Teaching NHS Trust

Stevenage, SG1 4AB, United Kingdom

RECRUITING

Study Officials

• Ananth Vijendren

  East and North Hertfordshire Teaching NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ananth Vijendren, BM, FRCS (ORL-HNS), PhD

CONTACT

+441438288019; Ananth.vijendren1@nhs.net

Toral Odedra

CONTACT

toral.odedra@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: September 24, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)