Recruiting

Prosthesis Comparison

Sponsor:

Össur Iceland ehf

Code:

NCT07915700

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prototype hand prosthesis

Baseline Comparator Device

Study Details

Brief summary:

This study asks individuals with upper limb absence to use a new hand prosthesis, and compare it's performance to their own hand prosthesis

Conditions

Amputation

Study ID

NCT07915700

Start date

Mar 9, 2026

Status verified date

Nov, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Multi-articulating hand experience
  • At least 18 years old
  • Transradial, acquired amputation or congenital upper limb absence
  • Unilateral upper limb absence preferred Good socket comfort in own prosthesis (>/= 6 on Hanspal socket comfort score)

Exclusion Criteria:

  • Any health conditions that pose a risk to participation in study events (in the opinion of the Investigator), e.g. Visual impairment; Cognitive impairment
  • Cognitively unable to provide informed consent or comply with the study procedures

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: All participants

All participants will use the prototype device

Interventions

Prototype hand prosthesis

Prototype hand prosthesis

Baseline Comparator Device

All participants will use their own prosthesis

Primary outcome measure

  • Grip Accuracy [ Time Frame: At baseline and each post-treatment visit (x3 visits over 12 weeks) ]

Central Contacts and Locations

Central contacts

Daire McGuinness

01506533178dmcguinness@ossur.com

Locations

Ossur Americas

Recruiting

Dublin, Ohio, United States, 43017

Contacts

Lynsay Emmrich

+16149278008lynsay.emmrich@emblamedical.com

More Information

Sponsor

Össur Iceland ehf

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Össur Iceland ehf on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.