The DEXTER-assisted Non-Emergent and Acute cholecyStecTomy Study (The NEST Study)

Distalmotion

Status: Completed

Conditions: Cholecystectomy

Treatments: Procedure: Cholecystectomy

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06473688

2024-02

Details and patient eligibility

About

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic cholecystectomy.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged > 18 years
• Patients planned to undergo elective robot-assisted and laparoscopic cholecystectomy; using one camera port, two ports for the manipulating instruments, and additional ports as needed.

Exclusion criteria

• Morbidly obese patients (BMI > 40)
• Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
• Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
• Bleeding diathesis
• Pregnancy
• Patients with pacemakers or internal defibrillators
• Any planned concomitant procedures
• Patient deprived of liberty by administrative or judicial decision
• Participation in another interventional clinical trial