Surgical Procedures, OperativeSCUDNCT01929928
Evaluation of Efficacy and Accuracy of a Cordless Ultrasonic Dissection System
An observational study of Surgical Procedures, Operative, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of a new cordless ultrasonic dissection system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedures, Operative
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2015
- 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 from the division of Hepatobiliary Surgery at Carolinas Medical Center in Charlotte, NC.
Who may be able to join
- General surgery in which an ultrasonic dissection device will be utilized Adult male and females age 18 and older
Who cannot join
- Surgery involving bone Surgery involving contraceptive tubal occlusion Indication for emergency surgery Suspected inability or the inability to comply with trial procedures Employee at the investigational center, sponsor or sponsor's representative, relative or spouse of the investigator Emergency Surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28204
About this study
Official title: Sonicision Cordless Ultrasonic Dissection System in General Surgery: A Prospective Post-market Observational Study to Evaluate the Efficacy and Accuracy of a Cordless Ultrasonic Dissection System
The purpose of this study is to test the efficacy of a new cordless ultrasonic dissection system.
Read the detailed description
The Sonicision device offers the ability to achieve hemostasis and vessel dissection with a cordless system. The ultrasonic device yields coagulation and transection of vessels by conversion of electrical energy into ultrasonic vibration through a piezoelectric or magnetic transducer, which is the causation of heat induction at the jaws of the instrument through friction. The Sonicision device is able to seal vessels up to 5 mm and transection division of 10 cm segments. The Sonicision device features the following:
- Cordless design to improve freedom and movement;
- Simplified set up that may possibly increase operating room efficiency;
- Dual-mode energy control to increase procedure focus;
- Improved mobility secondary to cordless system.
Currently all devices are connected to a generator by a cable, which can lead to the cable wrapping around the device, tangle with other instruments and become inadvertently contaminated. There are several advantages with regards to utilization of a cordless device to include: improved intra-operative storage, avoidance of bundling multiple cords from various instruments that may limit instrument mobility and portability which may lead to the ability to operate with advanced surgical equipment in third world settings, trauma and surgery centers.
The study group will consist of 150 patients, male and female adults, who present with the need for general surgery in which an ultrasonic dissection device and/or a vessel sealing device will be utilized. Patients will be identified prospectively via consultation with the general surgeon. Data will be collected addressing the following variables: versatility, dissection time, vessel diameter, reliability, efficiency, tissue response, steam production, blood loss, tissue response, thermal spread, desiccation and sealing time. A tentative total of ten individual tissue specimens will be obtained by the surgeon during surgery and after the utilization of the Sonicision Cordless Ultrasonic Dissection System. The patient's histologic sample will be followed after surgery in order to determine efficacy of the vessel seal. Subsequently, the patient's information will be deidentified and the patient assigned a study number to which all further analysis will be tied. Patient participation will include time of surgery through discharge from the hospital. Study data will be collected and managed utilizing an electronic database.
- Conditions
- Surgical Procedures, Operative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placement of Sonicision Cordless Ultrasonic Dissection Device
Evaluation of device placement will be measured based on vessel sealing variables: number of applications, vessel site, type of tissue to be sealed, number of seals to achieve hemostasis, number of activations, number of successful seals, number of failed seals, tissue sticking, tissue color, thermal spread and desiccation.
Measured: 1 year
Efficacy of Sonicision Cordless Ultrasonic Dissection Device
Efficacy of device will be measured based on intra-operative and post-operative complication variables: estimated blood loss, blood transfusion, complications intra-operative and post-operative.
Measured: 1 year
Secondary outcomes (1)
Device Complications
Functional evaluation of device based on the variables: device malfunction, number of battery and generator changes during a procedure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedures, OperativeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- David A Iannitti, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929928
- Sponsor's protocol ID
- 12-12-03B
- Acronym
- SCUD
- Status last verified
- Feb 2016
- First submitted
- 23 Aug 2013
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonicision Cordless Ultrasonic Dissection System in General Surgery: A Prospective Post-market Observational Study to Evaluate the Efficacy and Accuracy of a Cordless Ultrasonic Dissection System
- ClinicalTrials.gov ID
- NCT01929928
- Acronym / sponsor ID
- SCUD / 12-12-03B
- Conditions
- Surgical Procedures, Operative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Aug 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.
The purpose of this study is to test the efficacy of a new cordless ultrasonic dissection system.
Detailed description
The Sonicision device offers the ability to achieve hemostasis and vessel dissection with a cordless system. The ultrasonic device yields coagulation and transection of vessels by conversion of electrical energy into ultrasonic vibration through a piezoelectric or magnetic transducer, which is the causation of heat induction at the jaws of the instrument through friction. The Sonicision device is able to seal vessels up to 5 mm and transection division of 10 cm segments. The Sonicision device features the following:
- Cordless design to improve freedom and movement;
- Simplified set up that may possibly increase operating room efficiency;
- Dual-mode energy control to increase procedure focus;
- Improved mobility secondary to cordless system.
Currently all devices are connected to a generator by a cable, which can lead to the cable wrapping around the device, tangle with other instruments and become inadvertently contaminated. There are several advantages with regards to utilization of a cordless device to include: improved intra-operative storage, avoidance of bundling multiple cords from various instruments that may limit instrument mobility and portability which may lead to the ability to operate with advanced surgical equipment in third world settings, trauma and surgery centers.
The study group will consist of 150 patients, male and female adults, who present with the need for general surgery in which an ultrasonic dissection device and/or a vessel sealing device will be utilized. Patients will be identified prospectively via consultation with the general surgeon. Data will be collected addressing the following variables: versatility, dissection time, vessel diameter, reliability, efficiency, tissue response, steam production, blood loss, tissue response, thermal spread, desiccation and sealing time. A tentative total of ten individual tissue specimens will be obtained by the surgeon during surgery and after the utilization of the Sonicision Cordless Ultrasonic Dissection System. The patient's histologic sample will be followed after surgery in order to determine efficacy of the vessel seal. Subsequently, the patient's information will be deidentified and the patient assigned a study number to which all further analysis will be tied. Patient participation will include time of surgery through discharge from the hospital. Study data will be collected and managed utilizing an electronic database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the division of Hepatobiliary Surgery at Carolinas Medical Center in Charlotte, NC.
Key inclusion criteria (1 listed)
- General surgery in which an ultrasonic dissection device will be utilized Adult male and females age 18 and older
Key exclusion criteria (1 listed)
- Surgery involving bone Surgery involving contraceptive tubal occlusion Indication for emergency surgery Suspected inability or the inability to comply with trial procedures Employee at the investigational center, sponsor or sponsor's representative, relative or spouse of the investigator Emergency Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Placement of Sonicision Cordless Ultrasonic Dissection Device
Time frame: 1 year
Evaluation of device placement will be measured based on vessel sealing variables: number of applications, vessel site, type of tissue to be sealed, number of seals to achieve hemostasis, number of activations, number of successful seals, number of failed seals, tissue sticking, tissue color, thermal spread and desiccation.
Efficacy of Sonicision Cordless Ultrasonic Dissection Device
Time frame: 1 year
Efficacy of device will be measured based on intra-operative and post-operative complication variables: estimated blood loss, blood transfusion, complications intra-operative and post-operative.
1 secondary outcome
Device Complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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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.
David A Iannitti, MD principal investigator
Wake Forest University Health Sciences
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 Surgical Procedures, Operative, run by Wake Forest University Health Sciences at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Apr 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Placement of Sonicision Cordless Ultrasonic Dissection Device (time frame: 1 year). 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 27 Apr 2022.