NCT02262884

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

September 30, 2014

Last Update Submit

June 2, 2016

Conditions

Subcutaneous Emphysema

Outcome Measures

Primary Outcomes (5)

  • Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours

    Rate of insufflation device related subcutaneous emphysema(SCE)

    2 hours post procedure

  • Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours

    Rate of insufflation device related subcutaneous emphysema(SCE)

    4 hours post procedure

  • Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours

    Rate of insufflation device related subcutaneous emphysema(SCE)

    8 hours post procedure

  • Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours

    Rate of insufflation device related subcutaneous emphysema(SCE)

    12 hours post procedure

  • Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours

    Rate of insufflation device related subcutaneous emphysema(SCE)

    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)

    2, hours post procedure

  • Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)

    4 hours post procedure

  • Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)

    8 hours post procedure

  • Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)

    12 hours post procedure

  • Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)

    24 hours post procedure

Study Arms (3)

AIS @ 12mmHg pressure

ACTIVE COMPARATOR

SurgiQuest AirSeal Insufflation System (AIS) set at 12mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.

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.

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.

Device: Conventional Insufflation System (CIS)

Interventions

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.

AIS @ 12mmHg pressureAIS @ 15mmHg pressure
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.

CIS @ 15mmHg pressure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years of age;
  • Capable and willing to give informed consent;
  • Acceptable candidate for an elective, non-emergent robotic partial nephrectomy;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Conditions

Subcutaneous Emphysema

Condition Hierarchy (Ancestors)

EmphysemaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • James Porter, MD

    Swedish Medical Center, Seattle , WA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

cynthia Harris, BS

CONTACT

775-392-2970cindy@clinregconsult.com

Michael Daniel, BS,MS,MBA

CONTACT

775-392-2970MADaniel@clinregconsult.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 13, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations

US(3)