Prospective Evaluation of the Use of Thunderbeat Vessel S... | NCT01999296

Studies
Prospective Evaluation of the Use of Thunderbeat Vessel Sealing Device in Laparoscopic Surgery

NCT01999296

Sponsor

Cantonal Hosptal, Baselland

Status

Unknown status

Last Update Posted

Jul 17, 2015Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Indication for Laparoscopic Surgery (Any)

Interventions

Use of Thunderbeat (TM) in laparoscopic surgery

Countries

Switzerland

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Nov 15, 2013

First Submission Date that Met QC Criteria

Nov 26, 2013

First Posted Date

Dec 3, 2013Estimated

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

Jul 15, 2015

Last Update Posted Date

Jul 17, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daniel Steinemann, MD, Principal Investigator, Cantonal Hosptal, BasellandPrincipal Investigator

Lead Sponsor

Cantonal Hosptal, BasellandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

All patients undergoing laparoscopic visceral and gynecologic procedures using the combined bipolar and ultrasonic vessel sealing and dissection device Thunderbeat are entered in a prospective registry. Data will be analysed concerning the safe use of the instrument and perioperative blood loss.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing laparoscopic surgery			Device: Use of Thunderbeat (TM) in laparoscopic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use of Thunderbeat (TM) in laparoscopic surgery	Device		Patients undergoing laparoscopic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intra- and postoperative device-related complications		30 days
Use of additional vessel sealing devices		one day

Secondary Outcomes

Measure	Description	Time Frame
Perioperative Blood Loss		30 days
Duration of Surgery		one day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients undergoing laparoscopic visceral or gynecologic surgery
need for a vessel sealing device during surgery

Exclusion Criteria:

non able to understand informed consent or missing consent
age <18

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

Patients with an indication for laparoscopic visceral or gynecologic surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Baselland Bruderholz		Bruderholz		4101	Switzerland