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NCT06805045

Image-Guided Surgery In The Treatment Of Rectal Cancer (AR_CRC)

Recruiting now NA Last updated 3 February 2025
What this trial tests

NA trial testing augmented reality in Rectum Cancer in 50 participants. Currently enrolling.

Timeline
29 May 2024
Primary endpoint
1 October 2026
31 December 2027

Quick facts

Lead sponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingsingle
Primary purposetreatment
Enrollment50
Start date29 May 2024
Primary completion1 October 2026
Estimated completion31 December 2027
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →

Who can join

Adults 18 to 80, any sex, with Rectum Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed study is addressed to introduce new Image-Guided Surgery (IGS) tools to assist mini-invasive surgical procedures of anterior rectal resection (TME; TA-TME, TTSS) performed with laparoscopic or robotic procedure. In details, the idea is to provide augmented reality (AR) guidance during robotic-assisted and laparoscopic surgeries, by overlaying the preoperative 3D virtual anatomical models to intraoperative surgical images (3D AR guidance). To optimize the intraoperative view during the 3D AR guidance, AI-based algorithms will be developed to allow the real time detection and segmentation of surgical instruments, needed to provide instrument de-occlusion during AR robotic surgery. We use 3D modelling technology in surgical planning (7 case) and intra-operative navigation ( 2 cases). The pilot study focused to 3D virtual reconstruction of the pelvis, rectum and neurovascular structure to the test the feasibility of virtual reality to this type of anatomy. Implementation of reconstruction using 3D nerve sequence (3 Tesla MRI) was used for the last 3 cases. After the creation of a complete virtual model of pelvis and its structures the last two models were applied in the operating-room during a laparoscopic rectal resection with the ausilium of AI. The test has showed good results: a good overlap of the 3D structures to the real organs of the pelvis. The focus of this research was on developing support tools aimed at enhancing surgical safety. AR can assist surgeons in identifying vascular and nerve structures that are not always clearly visible during minimally invasive procedures, compensating for the lack of tactile perception and thereby improving overall surgical safety. The next step of the study is to evaluate its benefits and limitations in clinical practice to reduce the post-operative complications and oncological recurrence.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of augmented reality

Trials testing the same drug.

Other recruiting trials for Rectum Cancer

Currently open trials in the same condition.

Other IRCCS Azienda Ospedaliero-Universitaria di Bologna trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06805045.

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