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A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy

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ClinicalTrials.gov Identifier: NCT03937505
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Intuitive Surgical

Brief Summary:
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation. Stage A of the study will determine the safe optimal dose and Stage B will determine expanded safety and efficacy for intraoperative ureter structure delineation for the identified optimal dose in study participants.

Condition or disease Intervention/treatment Phase
Ureter Injury Drug: IS-001 Drug: No treatment Phase 2

Detailed Description:
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted surgery with the da Vinci® Surgical System and Firefly® imaging. Stage A will be a dose-escalation to determine the optimal dose for ureter visualization and Stage B will be an expanded safety and efficacy evaluation of the optimal dose. Stage B will include a no-drug safety control to evaluate the effects of surgery alone on the safety parameters of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stage A is a dose-cohort escalation to determine optimal efficacious dose, Stage B is an expanded safety and efficacy evaluation of the optimal dose with a no-drug safety control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2 Multi-Center Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Dose-escalation
Dose-cohort escalation of single intravenous injection of IS-001 starting with 20 mg (n=8), escalating in 20 mg increments until optimal dose is determined.
Drug: IS-001
intravenous injection of IS-001 investigational drug

Experimental: Optimal dose-characterization
Single intravenous injection of IS-001 at the optimal dose will be administered to subjects assigned to the treatment group. Safety control subjects will not receive any study drug but will undergo robotic surgery and all associated safety assessment clinical trial procedures.
Drug: IS-001
intravenous injection of IS-001 investigational drug

Drug: No treatment
no drug injection




Primary Outcome Measures :
  1. Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale [ Time Frame: 10 minutes post-dose ]
    Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.

  2. Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale [ Time Frame: 30 minutes post-dose ]
    Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.

  3. Surgeon Confidence of Ureter Visibility Assessed Post-Dose by Three-point Likert-type Scale [ Time Frame: 60 minutes post-dose ]
    Intra-operative surgeon rating of ureter visibility in surgical field in both Firefly® and standard white light comparator mode on a three point Likert-type scale where 0=No, 1=Uncertain and 2=Yes. Surgeon ureter visibility score will be compared between the two imaging conditions.

  4. Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale [ Time Frame: 10 minutes post-dose ]
    Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points.

  5. Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale [ Time Frame: 30 minutes post-dose ]
    Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points

  6. Surgeon Assessment of Relative Ureter Contrast Post-Dose on a Five-point Likert-type Scale [ Time Frame: 60 minutes post-dose ]
    Intra-operative surgeon rating of relative ureter contrast in surgical field in Firefly® light mode on a five point Likert-type scale where 0=No Fluorescence, 1=Iso-Fluorescence, 2=Mild Fluorescence, 3= Moderate Fluorescence and 4=Strong Fluorescence. Surgeon contrast score will be compared to contrast scores at other time-points.


Secondary Outcome Measures :
  1. Safety 12-Lead EKG Change from Baseline [ Time Frame: 6 hours ]
    12-Lead EKG change from baseline in QTc

  2. Safety Hematology Laboratory Assessments Change from Baseline [ Time Frame: 24 hours ]
    Complete blood count hematology laboratory parameters change from baseline

  3. Safety Hematology Laboratory Assessments Change from Baseline [ Time Frame: 14 days ]
    Complete blood count hematology laboratory parameters change from baseline

  4. Safety Blood Chemistry Panel Laboratory Assessments Change from Baseline [ Time Frame: 24 hours ]
    Comprehensive metabolic panel laboratory parameters change from baseline

  5. Safety Blood Chemistry Panel Laboratory Assessments Change from Baseline [ Time Frame: 14 days ]
    Comprehensive metabolic panel laboratory parameters change from baseline

  6. Safety Urinalysis Laboratory Assessments Change from Baseline [ Time Frame: 14 days ]
    Routine urinalysis laboratory assessment change from baseline

  7. Safety Adverse Events Monitoring [ Time Frame: 14 days ]
    Drug related adverse events monitoring through 14-days

  8. Pharmacokinetics Maximal Concentration (Cmax) of Drug Plasma Levels [ Time Frame: 0, 1-2 hours and 2-3 hours ]
    Maximal concentration of investigational drug-plasma levels (Cmax)

  9. Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero to Last Sampling (AUClast) [ Time Frame: 0, 1-2 hours and 2-3 hours ]
    Area under the plasma curve from t(0) to last plasma sample

  10. Pharmacokinetics Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUCinf) [ Time Frame: 0, 1-2 hours and 2-3 hours ]
    Area under the plasma curve from t(0) extrapolated to infinity

  11. Pharmacokinetics Drug Plasma Clearance (CL) [ Time Frame: 0, 1-2 hours and 2-3 hours ]
    Clearance of the investigational drug from plasma

  12. Pharmacokinetics Terminal Elimination Half-life (t1/2) [ Time Frame: 0, 1-2 hours and 2-3 hours ]
    Half-life of the investigational drug in plasma

  13. Pharmacokinetics Apparent Volume of Distribution (Vz) [ Time Frame: 0, 1-2 hours and 2-3 hours ]
    The apparent volume of distribution of the investigational drug

  14. Ureter Identification Efficacy on a Nominal Scale [ Time Frame: 10 minutes ]
    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes

  15. Ureter Identification Efficacy on a Nominal Scale [ Time Frame: 30 minutes ]
    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes

  16. Ureter Identification Efficacy on a Nominal Scale [ Time Frame: 60 minutes ]
    Independent reader assessment of ureter visibility of a 5 second video segment of the surgical field in both Firefly® and standard white light comparator mode on a nominal scale where 0=No and 1=Yes.

  17. Ureter Delineation Efficacy as Length of Line Drawn in Millimeters [ Time Frame: 10 minutes ]
    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

  18. Ureter Delineation Efficacy as Length of Line Drawn [ Time Frame: 30 minutes ]
    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.

  19. Ureter Delineation Efficacy as Length of Line Drawn [ Time Frame: 60 minutes ]
    Independent reader assessment of ureter delineation on a still frame of the surgical field in both Firefly® and standard white light comparator mode. Length of line drawn on still frame where ureter is visible to independent reader is compared between imaging conditions.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female subject is between the ages of 18 and 75, inclusive
  2. Subject is scheduled to undergo robotic hysterectomy using a da Vinci® surgical system with Firefly® fluorescent imaging
  3. Subject is willing and able to provide informed consent
  4. Subject is considered capable of complying with study procedures

Exclusion Criteria:

  1. Subject is pregnant or nursing
  2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  3. Subject has been diagnosed with or treated for cancer in the last 12 months.
  4. Subject is already enrolled in another investigational study
  5. Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937505


Contacts
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Contact: Alwin Klaassen, PhD 408-523-7457 alwin.klaassen@intusurg.com

Locations
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United States, Texas
Las Palmas Medical Center Not yet recruiting
El Paso, Texas, United States, 79902
Contact: Richard Farnam, MD         
Sponsors and Collaborators
Intuitive Surgical
Investigators
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Principal Investigator: Richard Farnam, MD Las Palmas Medical Center

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Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT03937505     History of Changes
Other Study ID Numbers: ISI-124804-2
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Intuitive Surgical:
robotic-assisted surgery
minimally invasive surgery