Subcutaneous EmphysemaTARPANNCT02262884
SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)
A study testing SurgiQuest AirSeal Insufflation System (AIS) and Conventional Insufflation System (CIS) in people with Subcutaneous Emphysema, run by SurgiQuest, Inc. at 3 sites in United States.
Trial summary
A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL NEPHRECTOMY Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subcutaneous Emphysema
- What is being tested?
- SurgiQuest AirSeal Insufflation System (AIS) and Conventional Insufflation System (CIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2014to Mar 2017
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent robotic partial nephrectomy;
Who cannot join
- Subjects will be excluded from participating in this Study if they meet any of the following criteria prior to initiation of the endoscopic procedure 1.Advanced refusal of blood transfusion, if necessary; 2.Active systemic or cutaneous infection or inflammation; 3 Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4.Uncontrolled diabetes mellitus 5.Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 6.Severe co-existing morbidities having a life expectancy of less than 30 days; 7.Currently involved in any other investigational clinical Studies; 8.Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; 9.Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 10.Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2); 11. Patients presenting with Ascites
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
cheryl Fittizzi, 551-996-2255, CFittizzi@HackensackUMC.org
Michael Stifelman, MD
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Heather Algren, RN, 206-386-2820, heather.algren@swedish.org
Adel Islam, (206) 215-6532, adel.islam@swedish.org
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Aleksandra Klim, RN MHS CCRC, 314-747-9781, klima@wudosis.wustl.edu
Robert Figenshau, MD
About this study
Official title: A Physician Preference Study of the Use of SurgiQuest AirSeal vs. Conventional Insufflation Systems for the Management of Pneumoperitoneum in Robotic Partial Nephrectomy .
A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL NEPHRECTOMY
Read the detailed description
A prospective, randomized, controlled multi-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSealTM Insufflation System (AIS) vs. Conventional Insufflation Systems (CIS) for the Management of pneumoperitoneum during Robotic Partial Nephrectomy. Subjects will be randomized in a 1:1:1 treatment device to control ratio into one of three (3) different study arms: 1) AIS @ 12mmHg pressure, 2) AIS @ 15mmHg pressure, and 3) CIS @ 15mmHg pressure. 189 randomized subjects distributed in three arms of 63 patients. The three study sites are targeted to enroll 63 patients each, 21 patients in each of the three (3) study arms. It is expected that this will take up to 6 months.
- Conditions
- Subcutaneous Emphysema
- Being tested
- SurgiQuest AirSeal Insufflation System (AIS), Conventional Insufflation System (CIS)
- Medical subject headings
- Subcutaneous Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgiQuest AirSeal Insufflation System (AIS)Device
Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
Conventional Insufflation System (CIS)Device
Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
| Study group | Role | What they receive |
|---|---|---|
| AIS @ 12mmHg pressure | Active comparator | SurgiQuest AirSeal Insufflation System (AIS) set at 12mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy. Receives: Device: SurgiQuest AirSeal Insufflation System (AIS) |
| AIS @ 15mmHg pressure | Active comparator | SurgiQuest AirSeal insufflation System (AIS) set at 15 mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy. Receives: Device: SurgiQuest AirSeal Insufflation System (AIS) |
| CIS @ 15mmHg pressure | Active comparator | Conventional Insufflation System (CIS) set at 15mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephectomy. Receives: Device: Conventional Insufflation System (CIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Measured: 2 hours post procedure
Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Measured: 4 hours post procedure
Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Measured: 8 hours post procedure
Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Measured: 12 hours post procedure
Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Measured: 24 hours post procedure
Secondary outcomes (5)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Measured: 2, hours post procedure
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Measured: 4 hours post procedure
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Measured: 8 hours post procedure
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Measured: 12 hours post procedure
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Measured: 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous EmphysemaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SurgiQuest, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Porter, MD, Principal investigator, Swedish Medical Center, Seattle , WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262884
- Sponsor's protocol ID
- PRT DD112313
- Acronym
- TARPAN
- Status last verified
- Jun 2016
- First submitted
- 30 Sep 2014
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physician Preference Study of the Use of SurgiQuest AirSeal vs. Conventional Insufflation Systems for the Management of Pneumoperitoneum in Robotic Partial Nephrectomy .
- ClinicalTrials.gov ID
- NCT02262884
- Acronym / sponsor ID
- TARPAN / PRT DD112313
- Conditions
- Subcutaneous Emphysema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- SurgiQuest, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 13 Oct 2014 (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.
A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL NEPHRECTOMY
Detailed description
A prospective, randomized, controlled multi-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSealTM Insufflation System (AIS) vs. Conventional Insufflation Systems (CIS) for the Management of pneumoperitoneum during Robotic Partial Nephrectomy. Subjects will be randomized in a 1:1:1 treatment device to control ratio into one of three (3) different study arms: 1) AIS @ 12mmHg pressure, 2) AIS @ 15mmHg pressure, and 3) CIS @ 15mmHg pressure. 189 randomized subjects distributed in three arms of 63 patients. The three study sites are targeted to enroll 63 patients each, 21 patients in each of the three (3) study arms. It is expected that this will take up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIS @ 12mmHg pressure | Active comparator | Device: SurgiQuest AirSeal Insufflation System (AIS)SurgiQuest AirSeal Insufflation System (AIS) set at 12mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy. |
| AIS @ 15mmHg pressure | Active comparator | Device: SurgiQuest AirSeal Insufflation System (AIS)SurgiQuest AirSeal insufflation System (AIS) set at 15 mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy. |
| CIS @ 15mmHg pressure | Active comparator | Device: Conventional Insufflation System (CIS)Conventional Insufflation System (CIS) set at 15mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent robotic partial nephrectomy;
Key exclusion criteria (2 listed)
- Subjects will be excluded from participating in this Study if they meet any of the following criteria prior to initiation of the endoscopic procedure 1.Advanced refusal of blood transfusion, if necessary; 2.Active systemic or cutaneous infection or inflammation; 3 Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4.Uncontrolled diabetes mellitus 5.Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 6.Severe co-existing morbidities having a life expectancy of less than 30 days; 7.Currently involved in any other investigational clinical Studies; 8.Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; 9.Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 10.Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2); 11. Patients presenting with Ascites
- -
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 |
|---|---|---|
| SurgiQuest AirSeal Insufflation System (AIS)Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg. | Device | AIS @ 12mmHg pressure, AIS @ 15mmHg pressure |
| Conventional Insufflation System (CIS)Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg. | Device | CIS @ 15mmHg pressure |
Primary outcome
Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours
Time frame: 2 hours post procedure
Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours
Time frame: 4 hours post procedure
Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours
Time frame: 8 hours post procedure
Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours
Time frame: 12 hours post procedure
Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours
Time frame: 24 hours post procedure
Rate of insufflation device related subcutaneous emphysema(SCE)
5 secondary outcomes
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Time frame: 2, hours post procedure
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Time frame: 4 hours post procedure
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Time frame: 8 hours post procedure
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Time frame: 12 hours post procedure
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Time frame: 24 hours post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
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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.
James Porter, MD principal investigator
Swedish Medical Center, Seattle , WA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurgiQuest AirSeal Insufflation System (AIS) and Conventional Insufflation System (CIS) in people with Subcutaneous Emphysema, run by SurgiQuest, Inc. at 3 sites 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 3 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 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cynthia Harris, BS (775-392-2970, cindy@clinregconsult.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours (time frame: 2 hours post procedure). The study lists 5 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 6 Jun 2016; AzTrials last refreshed its copy on 6 Nov 2026.