A Novel Augmented Reality System (ARssist) for the Assistant Surgeon in Robotic Assisted Surgery

NCT04304079 | Withdrawn

• 1 other identifier: CRE 2019.607-T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic prostatectomy is a surgery for treating localized prostate cancer. The ARssist system is a novel augmented reality system designed for the assistant surgeon, allowing delivery of augmented reality information via Microsoft HoloLens 2 (a head mount display developed by Microsoft) to better delineate the 3-D operative environment and enable better visualization. To date, there is no prospective study on the clinical performance and utilization of the ARssist system. This study is to evaluate the clinical feasibility and safety of the ARssist system during robotic surgery with the da Vinci Xi system.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Augmented reality; ARssist system

Outcome Measures

Primary Outcomes (1)

• 30-day complications

  Complications which occur within 30 days after the operation

  Thirty days after the allocated treatment

Secondary Outcomes (6)

• Performance parameters

  Immediately post-operative

• Performance parameters

  Immediately post-operative

• User-generated usability feedbacks

  Immediately post-operative

• Operating time

  Immediately post-operative

• Blood loss

  Immediately post-operative

Study Arms (1)

ARssist system

EXPERIMENTAL

The surgery will follow the same steps of a standard robotic assisted radical prostatectomy procedure, with the addition of the ARssist system used by the patient side surgeon.

Device: ARssist system

Interventions

ARssist system DEVICE

As stated in ARssist system arm description

ARssist system

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old with informed consent
• Suitable for minimally invasive surgery
• Clinically diagnosed with urological conditions that are indicated for robotic assisted radical prostatectomy with or without lymph node dissection

You may not qualify if:

• Body mass index ≥ 35 kg/m2
• Contraindication to general anaesthesia
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
• Untreated active infection
• Uncorrectable coagulopathy
• Presence of another malignancy or distant metastasis
• Emergency surgery

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (12)

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  PMID: 27555678 BACKGROUND

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  PMID: 20495980 BACKGROUND

• Al Janabi HF, Aydin A, Palaneer S, Macchione N, Al-Jabir A, Khan MS, Dasgupta P, Ahmed K. Effectiveness of the HoloLens mixed-reality headset in minimally invasive surgery: a simulation-based feasibility study. Surg Endosc. 2020 Mar;34(3):1143-1149. doi: 10.1007/s00464-019-06862-3. Epub 2019 Jun 18.

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jeremy Yuen Chun TEOH, MBBS, FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective case series to be conducted as a pilot study to evaluate the clinical feasibility and safety of the ARssist system during robotic surgery with the da Vinci Xi system.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: January 1, 2022
• Primary Completion: February 28, 2024
• Study Completion: May 31, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)