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NCT Number: NCT03937505

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

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.

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Key information

Conditions

Ureter Injury

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

George Washington University Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subject is pregnant or nursing
  • Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • 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

Treatment and study plan

IS-001

Drug

intravenous injection of IS-001 investigational drug

no treatment

Drug

no drug injection

Primary outcomes

  1. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 10 minutes

    Fluorescent intensity of ureter evaluated as signal to background

  2. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 30 minutes

    Fluorescent intensity of ureter evaluated as signal to background

  3. Evaluate fluorescent intensity of ureter by signal to background analysis

    Time frame: 60 minutes

    Fluorescent intensity of ureter evaluated as signal to background

Secondary outcomes

  1. Safety 12-Lead EKG Change from Baseline

    Time frame: 6 hours

    12-Lead EKG change from baseline in QTc

  2. Incidence of abnormal blood work in tests results

    Time frame: 24 hours

    Safety hematology complete blood count laboratory assessments Change from Baseline

  3. Incidence of abnormal blood work in tests results

    Time frame: 14 days

    Safety hematology complete blood count laboratory assessments Change from Baseline

  4. Incidence of abnormal blood work in tests results

    Time frame: 24 hours

    Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline

  5. Incidence of abnormal blood work in tests results

    Time frame: 14 days

    Safety hematology comprehensive metabolic panel laboratory assessments Change from Baseline

  6. Incidence of abnormal urinalysis results

    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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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

  25. 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.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Phase 2 Multi-Center Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Gynecological Surgery Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 3, 2019
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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