Abdominal Cancer Clinical Trial
Official title:
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery
NCT number | NCT05637359 |
Other study ID # | IRBd20-141 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 13, 2020 |
Est. completion date | December 14, 2021 |
Verified date | November 2022 |
Source | The Netherlands Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The goal of this observational pilot study is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation? Participants will undergo tracked ultrasound measurements of the pelvic bone on the operating room after patient anesthesia and before surgical incision.
Status | Completed |
Enrollment | 26 |
Est. completion date | December 14, 2021 |
Est. primary completion date | December 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 - Patients scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled CBCT-scan in the OR - Patients provide written 'informed consent' Exclusion Criteria: - No exclusion criteria |
Country | Name | City | State |
---|---|---|---|
Netherlands | Netherlands Cancer Institute | Amsterdam | North Holland |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of tracked ultrasound registration. | To evaluate the accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. This will be assessed using the target registration error in mm, where a lower error means a better outcome. | One day | |
Secondary | Influence of patient position alteration on registration accuracy. | What is the influence of patient position alteration on the surgical navigation accuracy for standard Cone Beam CT and tracked ultrasound registration methods? This will be assessed using the target registration discrepancy in mm. | One day | |
Secondary | Measurement time of tracked ultrasound registration. | The time duration of ultrasound measurements will be recorded and compared with the conventional Cone Beam CT method. A faster ultrasound measurement time means a better outcome. | One day |
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