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Research to evaluate the usefulness of artificial intelligence-based surgical navigation systems

A Multicenter Randomized Controlled Trial Comparing With and Without Artificial Intelligence-based Intraoperative Image Navigation System Use in Laparoscopic Surgery - ImNavi trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050701
Enrollment
90
Registered
2023-03-31
Start date
2023-06-20
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

colorectal tumor

Interventions

Perform the surgery as usual, and verbally declare that the target organ for recognition has appeared on the screen at the time it is recognized. Perform the surgery using an AI-based navigation syste

Sponsors

National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients between 18 and 80 years of age, who are scheduled to undergo laparoscopic left-sided colorectal resection will be included in the ImNavi trial. As long-term outcomes are not included in the endpoints, patients with any colorectal diseases will be eligible.

Exclusion criteria

Exclusion criteria: Patients with emergent surgery, with expected intra-abdominal severe adhesion, with a significant anatomical anomaly, and deemed unsuitable by the doctor in charge will be excluded.

Design outcomes

Primary

MeasureTime frame
the time required for each target organ to be recognized by surgeons after its initial appearance on the monitor.

Secondary

MeasureTime frame
intraoperative target organ injuries, intraoperative complications, operation time, blood loss, length of postoperative hospital stay, postoperative complications within 30 days, postoperative male sexual dysfunction at 1 month after surgery, surgeon's confidence in recognition of each target organ, and postoperative fatigue of the primary surgeon according to the Piper Fatigue Scale-12.

Countries

Japan

Contacts

Public ContactDaichi Kitaguchi

National Cancer Center Hospital East Department for the Promotion of Medical Device Innovation

dkitaguc@east.ncc.go.jp0471331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026