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Completed

NCT Number: NCT06473688

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

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.

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Key information

Conditions

Cholecystectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Saintes - Saint-Jean-d'Angély, Saintes, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy

Procedure

Robotic-assisted and laparoscopic cholecystectomy

Primary outcomes

  1. primary safety endpoint

    Time frame: up to 30 days

    occurrence of Clavien - Dindo grades III-V adverse events

  2. primary performance endpoint

    Time frame: intraoperative

    successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach

Sponsors and collaborators

Lead sponsor

Distalmotion SA

Industry

Collaborators

  • Confinis

Registry information

Official study title

The DEXTER-assisted Non-emergent and Acute Cholecystectomy Study

Acronym: NEST

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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