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

Indication for Laparoscopic Surgery (Any) Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01999296
• Other study ID #: Thunderbeat in Laparoscopy
• Status: Active, not recruiting
• Phase: N/A
• First received: November 15, 2013
• Last updated: July 15, 2015
• Start date: October 2013

Study information

• Verified date: July 2015
• Source: Cantonal Hosptal, Baselland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Indication for Laparoscopic Surgery (Any)

Intervention

Device:
• Use of Thunderbeat (TM) in laparoscopic surgery

Locations

Country	Name	City	State
Switzerland	Kantonsspital Baselland Bruderholz	Bruderholz

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hosptal, Baselland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra- and postoperative device-related complications		30 days	Yes
Primary	Use of additional vessel sealing devices		one day	No
Secondary	Perioperative Blood Loss		30 days	Yes
Secondary	Duration of Surgery		one day	No