Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-29 @ 12:22 AM
Study NCT ID:
NCT01534832
Status:
COMPLETED
Last Update Posted:
2012-08-15
First Post:
2012-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy
Sponsor:
Asalus Medical Instruments Limited
Organization:
Study Overview
Official Title:
Assessment of a New Surgical Smoke Clearing Technology, "Innervision", in Laparoscopic Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Innervision
Brief Summary:
The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.
Detailed Description:
The study will examine the safety and performance of a new surgical smoke clearance system which has been developed to maintain a visually clear operative field during laparoscopic surgery by using electrostatic precipitation to clear, from the surgical field, smoke and plume produced by energy based surgical instruments e.g. electrocautery, laser tissue ablation and ultrasonic scalpel tissue dissection.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: