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NCT06805045
Image-Guided Surgery In The Treatment Of Rectal Cancer (AR_CRC)
NA trial testing augmented reality in Rectum Cancer in 50 participants. Currently enrolling.
1 October 2026
Quick facts
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 29 May 2024 |
| Primary completion | 1 October 2026 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- augmented reality
Conditions studied
- Rectum Cancer — all drugs for Rectum Cancer →
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.
Verify or expand the search:
- PubMed search for NCT06805045
- Europe PMC full search
- ASCO Meeting Library
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Currently open trials in the same condition.
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Other IRCCS Azienda Ospedaliero-Universitaria di Bologna trials
Trials by the same sponsor.
- NCT06718049 — Role of Interleukin 18 (IL-18) and Interleukin 18 Binding Protein (IL-18BP) in the Diagnostic Work-up of Systemic Juveni · not yet recruiting
- NCT07490392 — Growth and Endocrinological Outcomes in Patients Who Underwent or Did Not Undergo Haematopoietic Stem Cell Transplantati · not yet recruiting
- NCT07483853 — Reliability and Validation of the WB-MRI Radiological Score in CRMO · recruiting
- NCT07479121 — These Studies Assess Surgeons' Physical and Ergonomic Workloads. Study 1 Compares Laparoscopic vs. Hugo RAS Robotic Appr · NA · not yet recruiting
- NCT07471009 — Development of Patient Derived Xenografts (PDXs) and Analysis of Tyrosine Kinase Receptor Expression in Patients With Sq · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06805045 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Last refreshed: 3 February 2025
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