Feasibility of in vivo image-guided navigation during robotic sentinel node removal

Feasibility of in vivo image-guided navigation during robotic sentinel node removal - Image-guided navigation during robotic sentinel node removal

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54304

Enrollment

Registered

2021-08-17

Start date

2022-03-02

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

surgical and medical procedures - sentinel node dissection Sentinel node metastasis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Scheduled for abdominal robotic sentinel node resection - >= 18 years old - Provided written *informed consent* - SN should be fixed relative to retroperitoneal structures or major vessels

Exclusion criteria

Exclusion criteria: - Metal hip implants / implants in the pelvic area - Pacemaker, defibrillator

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the feasibility of electromagnetic navigation during robot-assisted sentinel node dissection. Electromagnetic navigation is considered feasible if in 75% of the sentinel node procedures the technology can be applied successfully. In order to quantify the primary study parameter the percentage of successfully removed sentinel nodes will be taken into account. Success is defined when a sentinel node is correctly localized with navigation and perioperative validated with the gamma probe. Failure of using the navigation per sentinel node would be either not removing a target sentinel node or removing per-operatively incorrectly identified target sentinel node.	—

Measure

Time frame

The main study endpoint is the feasibility of electromagnetic navigation during robot-assisted sentinel node dissection. Electromagnetic navigation is considered feasible if in 75% of the sentinel node procedures the technology can be applied successfully. In order to quantify the primary study parameter the percentage of successfully removed sentinel nodes will be taken into account. Success is defined when a sentinel node is correctly localized with navigation and perioperative validated with the gamma probe. Failure of using the navigation per sentinel node would be either not removing a target sentinel node or removing per-operatively incorrectly identified target sentinel node.

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Secondary

Measure	Time frame
The first secondary study parameter is the time to localize and remove the sentinel node, together with the added time to surgery due to deploying navigation. The SUS-score will be used to evaluate the usability of the navigation within the surgery. The last study parameter will be the evaluation of the sentinel node size versus the success rate.	—

Countries

Netherlands

Outcome results