NCT01999296

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

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

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

November 15, 2013

Last Update Submit

July 15, 2015

Conditions

Indication for Laparoscopic Surgery (Any)

Outcome Measures

Primary Outcomes (2)

  • Intra- and postoperative device-related complications

    30 days

  • Use of additional vessel sealing devices

    one day

Secondary Outcomes (2)

  • Perioperative Blood Loss

    30 days

  • Duration of Surgery

    one day

Study Arms (1)

Patients undergoing laparoscopic surgery

Device: Use of Thunderbeat (TM) in laparoscopic surgery

Interventions

Use of Thunderbeat (TM) in laparoscopic surgeryDEVICE
Patients undergoing laparoscopic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an indication for laparoscopic visceral or gynecologic surgery.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baselland Bruderholz

Bruderholz, 4101, Switzerland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2013

First Posted

December 3, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

CH(1)