Indication for Laparoscopic Surgery (Any)NCT01999296
Prospective Evaluation of the Use of Thunderbeat Vessel Sealing Device in Laparoscopic Surgery
An observational study of Indication for Laparoscopic Surgery (Any), run by Cantonal Hospital, Baselland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indication for Laparoscopic Surgery (Any)
- What is being tested?
- Use of Thunderbeat (TM) in laparoscopic surgery
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2013to Dec 2015
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for laparoscopic visceral or gynecologic surgery.
Who may be able to join
- all patients undergoing laparoscopic visceral or gynecologic surgery
- need for a vessel sealing device during surgery
Who cannot join
- non able to understand informed consent or missing consent
- age <18
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Use of Thunderbeat (TM) in laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Thunderbeat (TM) in laparoscopic surgeryDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing laparoscopic surgery | Not described Receives: Device: Use of Thunderbeat (TM) in laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra- and postoperative device-related complications
Measured: 30 days
Use of additional vessel sealing devices
Measured: one day
Secondary outcomes (2)
Perioperative Blood Loss
Measured: 30 days
Duration of Surgery
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for Laparoscopic Surgery (Any)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Baselland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Steinemann, MD, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999296
- Sponsor's protocol ID
- Thunderbeat in Laparoscopy
- Status last verified
- Jul 2015
- First submitted
- 15 Nov 2013
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Use of Thunderbeat Vessel Sealing Device in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01999296
- Acronym / sponsor ID
- Thunderbeat in Laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cantonal Hospital, BasellandUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing laparoscopic surgery | – | Device: Use of Thunderbeat (TM) in laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for laparoscopic visceral or gynecologic surgery.
Key inclusion criteria (2 listed)
- all patients undergoing laparoscopic visceral or gynecologic surgery
- need for a vessel sealing device during surgery
Key exclusion criteria (2 listed)
- non able to understand informed consent or missing consent
- age <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Thunderbeat (TM) in laparoscopic surgery | Device | Patients undergoing laparoscopic surgery |
Primary outcome
Intra- and postoperative device-related complications
Time frame: 30 days
Use of additional vessel sealing devices
Time frame: one day
2 secondary outcomes
Perioperative Blood Loss
Time frame: 30 days
Duration of Surgery
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indication for Laparoscopic Surgery (Any), run by Cantonal Hospital, Baselland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra- and postoperative device-related complications (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.