Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis (Ultravision)
Primary Purpose
Cholecystitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
medical device with CE marking (Ultravision ©)
Sponsored by
About this trial
This is an interventional other trial for Cholecystitis
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
Sites / Locations
- Assistance Publique Des Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EXPERIMENTAL GROUP
CONTROL GROUP
Arm Description
A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch on
A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch off
Outcomes
Primary Outcome Measures
operating time
the time of the surgery calculated from the incision to the dressing (as is done routinely for each procedure on anesthesia protocols).
Secondary Outcome Measures
Full Information
NCT ID
NCT03636841
First Posted
August 16, 2018
Last Updated
August 16, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03636841
Brief Title
Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis
Acronym
Ultravision
Official Title
Reduction of Operating Time by a Smoke Electroprecipitation Device: Randomized Controlled Study on Laparoscopic Cholecystectomy for Acute Cholecystitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch on
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
A group of 30 patients using the new medical device with CE marking (Ultravision ©) switch off
Intervention Type
Device
Intervention Name(s)
medical device with CE marking (Ultravision ©)
Intervention Description
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.
Primary Outcome Measure Information:
Title
operating time
Description
the time of the surgery calculated from the incision to the dressing (as is done routinely for each procedure on anesthesia protocols).
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
thierry bege, md
Phone
+33 491372825
Email
Thierry.BEGE@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emilie garrido pradalie
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Des Hopitaux de Marseille
City
Marseille
State/Province
Paca
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
THIERRY BEGE, MD
Phone
+33491372825
Email
Thierry.BEGE@ap-hm.fr
12. IPD Sharing Statement
Learn more about this trial
Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis
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