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

July 15, 2015 updated by: Daniel Steinemann, MD, Cantonal Hosptal, Baselland
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bruderholz, Switzerland, 4101
        • Kantonsspital Baselland Bruderholz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with an indication for laparoscopic visceral or gynecologic surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing laparoscopic surgery
Device: Use of Thunderbeat (TM) in laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hosptal, Baselland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (ESTIMATE)

December 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Thunderbeat in Laparoscopy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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