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First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies

NCT03901209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-09-28

No results posted yet for this study

Summary

The study product is a Cold Ablation Robot-guided Laser Osteotome (CARLO®) robotic surgery device. It is a device that removes hard tissue such as bone by means laser ablation - it is therefore an alternative to Piezo-Electric osteotomes and/or oscillating saws or other mechanical instruments for bone cutting. In this study, the CARLO device is integrated with a computer-assisted pre-operative planning and intra-operative navigation, and will be used for Patients requiring an orthognathic procedure with a mid-face osteotomy, for whom a procedure plan is defined based on preoperative imaging.

Conditions

  • Abnormalities, Jaw
  • Malocclusion, Angle Class III

Interventions

DEVICE

Mid-face osteotomy

The mid-face osteotomy - typically according to LeFort I - is performed using a pulsed erbium-doped yttrium aluminium garnet (Er:YAG) laser driven by the CARLO robot arm.

Sponsors & Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

    collaborator OTHER

  • Advanced Osteotomy Tools (AOT) AG

    lead INDUSTRY

Principal Investigators

  • Andreas Müller · Universitätsspital Basel

  • Marcello Augello · Kantonsspital Aarau

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-08-28
Completion
2020-08-28

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03901209 on ClinicalTrials.gov