HARMONY

Robotic Liver Resection and Cone Beam CT-guided Percutaneous Ablation of Colorectal Liver Metastases in a Hybrid Operating Room (HARMONY) - HARMONY

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57678

Enrollment

Registered

2025-02-03

Start date

2025-07-16

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal liver metastasis

Interventions

Concurrent robotic resection and cone beam CT-guided percutaneous ablation in a hybrid operating room.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults (=18 years of age), eligible for local treatment of colorectal liver metastases using a combination of robotic resection and CT-guided ablation

Exclusion criteria

Exclusion criteria: Any contraindication for robotic liver resection or CT-guided percutaneous ablation of colorectal liver metastases.No informed consent.

Design outcomes

Primary

Measure	Time frame
The main study endpoint is feasibility of the HARMONY procedure, defined as the technical success of both the robotic surgical resection and C-arm CT-guided ablation within the hybrid operating room. Surgical technical success is defined as treatment according to protocol and full resection of the target lesion confirmed using ICG fluorescence imaging. Ablation technical success is defined as treatment according to protocol and lesion covered completely by the ablation zone, confirmed using ablation confirmation software.	—

Measure

Time frame

The main study endpoint is feasibility of the HARMONY procedure, defined as the technical success of both the robotic surgical resection and C-arm CT-guided ablation within the hybrid operating room. Surgical technical success is defined as treatment according to protocol and full resection of the target lesion confirmed using ICG fluorescence imaging. Ablation technical success is defined as treatment according to protocol and lesion covered completely by the ablation zone, confirmed using ablation confirmation software. 

—

Secondary

Measure	Time frame
Other study parameters include short-term periprocedural outcomes, including morbidity.	—

Countries

Netherlands

Contacts

Public ContactR.J. Swijnenburg

Amsterdam UMC

r.j.swijnenburg@amsterdaumc.nl020 444 4444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)