Novel Robotic Surgical System for Minimally Invasive Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-24

Study Completion Date

2024-01-30

Brief Summary

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This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

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Detailed Description

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This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

Conditions

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Robotic Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic Surgery

Prospective single arm study to investigate effect of a novel robotic surgical system on safety, efficacy and outcomes for performance of minimally invasive surgery across urology, upper and lower GI surgery.

Group Type EXPERIMENTAL

K2 Robotic Surgical System

Intervention Type DEVICE

The K2 Robotic Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery in the thorax and abdomen. The K2 Robotic Surgical System consists of a Surgeon Console \[SGC\], a Patient Side Robot \[PSR\], and a Vision Cart \[VCT\], and is used with an endoscope, Surgical Instruments \[SGI\], and Accessories \[ACC\]. The surgeon views the three-dimensional endoscopic image on a High-Resolution Stereo Viewer (3D Viewer), which provides a view of the abdominal cavity and surgical instrumentation, along with icons and other user interface features.

Interventions

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K2 Robotic Surgical System

The K2 Robotic Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery in the thorax and abdomen. The K2 Robotic Surgical System consists of a Surgeon Console \[SGC\], a Patient Side Robot \[PSR\], and a Vision Cart \[VCT\], and is used with an endoscope, Surgical Instruments \[SGI\], and Accessories \[ACC\]. The surgeon views the three-dimensional endoscopic image on a High-Resolution Stereo Viewer (3D Viewer), which provides a view of the abdominal cavity and surgical instrumentation, along with icons and other user interface features.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Body mass index \<35 kg/m2
2. Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases
3. Willingness to participate as demonstrated by giving informed consent

Exclusion Criteria

1. Contraindication to general anesthesia
2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
3. Untreated active infection
4. Noncorrectable coagulopathy
5. Presence of another malignancy or distant metastasis
6. Emergency surgery
7. Vulnerable population (e.g. mentally disabled, pregnancy)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No