NCT03636841

Brief Summary

The smoke produced by the electric section of the tissues during laparoscopy alters the vision of the operative field and presents potential risks. A new medical device with CE marking (Ultravision ©) has been developed to limit electroprecipitation on the wall and tissues of the abdomen. The aim of the work is to evaluate the effectiveness of this medical device in laparoscopic cholecystectomy for cholecystitis. It is an intervention for a common pathology where smoke is particularly important due to the tissue inflammation and due to the extensive dissection necessary to perform the surgical procedure. A randomized double-blinded study will be conducted in two academic hospitals (Marseille North Hospital and Timone, APHM) evaluating the use of a smoke electroprecipitation device (Ultravision ©) during laparoscopic cholecystectomy for cholecystitis operated at the acute phase. A group of 30 patients using the device will be compared to a control group of 30 patients. The evaluation will last thirty days per patient and the duration of inclusion is 2 years. The main objective is to demonstrate a significant reduction in operating duration by using the device. The secondary objectives are to reduce the CO2 consumption, the surgical incidents and the discomfort of the surgeon related to the smoke.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

August 16, 2018

Last Update Submit

August 16, 2018

Conditions

Cholecystitis

Outcome Measures

Primary Outcomes (1)

  • operating time

    the time of the surgery calculated from the incision to the dressing (as is done routinely for each procedure on anesthesia protocols).

    2 hours

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch on

Device: medical device with CE marking (Ultravision ©)

CONTROL GROUP

ACTIVE COMPARATOR

A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch off

Device: medical device with CE marking (Ultravision ©)

Interventions

medical device with CE marking (Ultravision ©)DEVICE

Ultravision © is a medical device that is used during laparoscopy to reduce the discomfort caused by surgical smoke produced by the electrical section of tissue. It works by using the principle of electrostatic precipitation, that is to say it causes the precipitation of suspended smoke droplets on the organs and walls of the abdomen.

CONTROL GROUPEXPERIMENTAL GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult\> 18 years old
  • Ability to accept consent
  • Acute documented cholecystitis (pain\> 6h, thickening of vesicular wall on ultrasound, biological inflammatory syndrome)
  • Patient operated within 5 days of onset of signs
  • Surgery decided by laparoscopy

You may not qualify if:

  • Pregnant woman
  • Atcd umbilical abdominal surgery
  • Achievement of the open subcostal intervention
  • Patient under anticoagulant
  • Patient ASA3
  • Age \<75 years
  • BMI\> 45
  • icteric cholestasis on preoperative laboratory examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Cholecystitis

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • emilie garrido pradalie

    APHM

    STUDY DIRECTOR

Central Study Contacts

thierry bege, md

CONTACT

+33 491372825Thierry.BEGE@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 17, 2018

Study Start

September 1, 2018

Primary Completion

November 1, 2020

Study Completion

May 1, 2021

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

FR(1)