NCT03901209

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

Completed NA Last updated 28 September 2020

What this trial tests

NA trial testing Mid-face osteotomy in Abnormalities, Jaw in 31 participants. Completed in 28 August 2020.

Timeline

1 July 2019

Primary endpoint
28 August 2020

28 August 2020

Quick facts

Lead sponsor	Advanced Osteotomy Tools (AOT) AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	1 July 2019
Primary completion	28 August 2020
Estimated completion	28 August 2020
Sites	4 locations across Austria, Switzerland, Germany

Drugs / interventions tested

• Mid-face osteotomy

Conditions studied

• Abnormalities, Jaw — all drugs for Abnormalities, Jaw →
• Malocclusion, Angle Class III — all drugs for Malocclusion, Angle Class III →

Sponsor

Advanced Osteotomy Tools (AOT) AG

Who can join

18 and older, any sex, with Abnormalities, Jaw or Malocclusion, Angle Class III. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cold Ablation Robot-Guided Laser Osteotome (CARLO^®): From Bench to Bedside.
   Ureel M, Augello M, Holzinger D, Wilken T, et al · · 2021 · cited 16× · PMID 33498921 · DOI 10.3390/jcm10030450
2. Cold ablation robot-guided laser osteotomy in hand, wrist and forearm surgery-A feasibility study.
   Honigmann P, Hofer M, Hirsch S, Morawska M, et al · · 2022 · cited 9× · PMID 35770622 · DOI 10.1002/rcs.2438
3. Performance and safety evaluation of a cold ablation robot-guided laser osteotome (CARLO) in 28 midface osteotomies.
   Köhnke R, Chin SJ, Assaf AT, Helmbold K, et al · · 2024 · cited 3× · PMID 39511241 · DOI 10.1038/s41598-024-68557-7