Reduction of Operating Time by a Smoke Electroprecipitati... | NCT03636841

Studies
Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis

NCT03636841

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Aug 17, 2018Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Cholecystitis

Interventions

medical device with CE marking (Ultravision ©)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2018Estimated

Primary Completion Date

Nov 2020Estimated

Completion Date

May 2021Estimated

First Submitted Date

Aug 16, 2018

First Submission Date that Met QC Criteria

Aug 16, 2018

First Posted Date

Aug 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2018

Last Update Posted Date

Aug 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Context and purpose of the work:

Material and method 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.

Expected results 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
thierry bege, md	Contact	+33 491372825		Thierry.BEGE@ap-hm.fr

Overall Officials

Name	Affiliation	Role
emilie garrido pradalie	APHM	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Des Hopitaux de Marseille		Marseille	PACA	13354	France

Condition Browse Module

MeSH Terms

ID	Term
D002764	Cholecystitis

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004864	Equipment and Supplies

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided