MedTrace Logo

Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy

NCT03380572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-05-21

Study results available
· View outcomes & findings →

Summary

The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy.

Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.

Conditions

  • Biliary Colic
  • Cholecystitis

Interventions

DEVICE

Senhance Assisted Cholecystectomy

Cholecystectomy performed using Senhance surgical robotic system

PROCEDURE

Laparoscopic Cholecystectomy

Standard laparoscopic cholecystectomy

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Sanjay Purkayastha, MD · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2017-12-01
Completion
2018-01-01
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380572 on ClinicalTrials.gov