HysterectomyPhase 1NCT03006237
IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics
A Phase 1 study testing IS-001 and da Vinci® Si/Xi Surgical System in people with Hysterectomy and Surgery, run by Intuitive Surgical at 1 site in United States.
Trial summary
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy, Surgery
- What is being tested?
- IS-001 and da Vinci® Si/Xi Surgical System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2017
- Phase
- Phase 1
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is between the ages of 18 and 65.
- Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging.
- Subject is willing and able to provide informed consent.
- Subject is considered capable of complying with study procedures.
- Subject has no medical history of liver or kidney disease.
- Subject has no evidence of NYHA Class II-IV cardiac disease.
- Subject has recent (< 3 months) clinical hematology (CBC) values within the acceptable values reference range.
- Subject has recent (< 3 months) clinical serum chemistry (CMP) values within the acceptable values reference range.
Who cannot join
- Subject is pregnant or nursing.
- Subject has a history of alcoholism.
- Subject has a history of drug abuse.
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Subject has known human immunodeficiency virus (HIV) infection.
- Subject has been diagnosed with or treated for cancer in the last 2 years.
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- Subject has a total body weight < 32 kg.
- Subject has after 5 minutes of supine rest a diastolic blood pressure ≥100 mmHg and/or a systolic blood pressure ≥160 mmHg.
- Subject has after 5 minutes of supine rest a resting heart rate ≤35 or ≥115 bpm.
- Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data or represents an unacceptable safety liability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System With Firefly® Fluorescent Imaging
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
Read the detailed description
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
- Conditions
- Hysterectomy, Surgery
- Being tested
- IS-001, da Vinci® Si/Xi Surgical System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IS-001Drug
10mg, 20mg or 40 mg IV IS-001 drug administered during surgery
da Vinci® Si/Xi Surgical SystemDevice
robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
| Study group | Role | What they receive |
|---|---|---|
| IV IS-001 drug | Experimental | IV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System Receives: Drug: IS-001; Device: da Vinci® Si/Xi Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events
Measured: 14 days
Secondary outcomes (4)
Evaluation of pharmacokinetic parameter of IS-001: Cmax
Pharmacokinetics for IS-001 as measured by maximum serum/drug concentration
Measured: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: Tmax
Pharmacokinetics for IS-001 as measured by the time to maximum serum/drug concentration
Measured: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: t1/2
Pharmacokinetics for IS-001 as measured by terminal elimination half-life
Measured: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: AUC
Pharmacokinetics for IS-001 as measured by area under the serum/drug concentration time curve
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Farnam, MD, Principal investigator, Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006237
- Sponsor's protocol ID
- ISI-001-01
- Status last verified
- Mar 2018
- First submitted
- 14 Dec 2016
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Farnam RW, Arms RG, Klaassen AH, Sorger JM. Intraoperative ureter visualization using a near-infrared imaging agent. J Biomed Opt. 2019 Jun;24(6):1-8. doi: 10.1117/1.JBO.24.6.066004.
PubMed 31215195
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System With Firefly® Fluorescent Imaging
- ClinicalTrials.gov ID
- NCT03006237
- Acronym / sponsor ID
- ISI-001-01
- Conditions
- Hysterectomy, Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Dec 2016 (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 Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001
Detailed description
A Phase 1 Open Label Single Center Safety, Tolerability and Pharmacokinetic Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy Using the da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV IS-001 drug | Experimental | Drug: IS-001, Device: da Vinci® Si/Xi Surgical SystemIV IS-001 given during hysterectomy performed with da Vinci® Si/Xi Surgical System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is between the ages of 18 and 65.
- Subject is scheduled to undergo robotic hysterectomy using a da Vinci® Si/Xi surgical system with Firefly® fluorescent imaging.
- Subject is willing and able to provide informed consent.
- Subject is considered capable of complying with study procedures.
- Subject has no medical history of liver or kidney disease.
Key exclusion criteria (10 listed)
- Subject is pregnant or nursing.
- Subject has a history of alcoholism.
- Subject has a history of drug abuse.
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Subject has known human immunodeficiency virus (HIV) infection.
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 |
|---|---|---|
| IS-00110mg, 20mg or 40 mg IV IS-001 drug administered during surgery | Drug | IV IS-001 drug |
| da Vinci® Si/Xi Surgical Systemrobot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging | Device | IV IS-001 drug |
Primary outcome
Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events)
Time frame: 14 days
Vital signs, 12-lead ECG, serum chemistry (CMP) and hematology (CBC), urinalysis and incidence of treatment-emergent adverse events
4 secondary outcomes
Evaluation of pharmacokinetic parameter of IS-001: Cmax
Time frame: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: Tmax
Time frame: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: t1/2
Time frame: 6 hours
Evaluation of pharmacokinetic parameter of IS-001: AUC
Time frame: 6 hours
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 5 Mar 2018.
- Derived from this study: PubMed 31215195Farnam RW, Arms RG, Klaassen AH, Sorger JM. Intraoperative ureter visualization using a near-infrared imaging agent. J Biomed Opt. 2019 Jun;24(6):1-8. doi: 10.1117/1.JBO.24.6.066004.
- Individual participant dataSharing planned: Undecided
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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.
Richard Farnam, MD principal investigator
Texas Urogynecology and Laser Surgery Center, Las Palmas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IS-001 and da Vinci® Si/Xi Surgical System in people with Hysterectomy and Surgery, run by Intuitive Surgical 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 8 inclusion and 10 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 5 Mar 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Monitor Safety Parameters (vital signs, ECG, serum chemistry and hematology, urinalysis and adverse events) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03006237, which also lists 1 linked publication.
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 5 Mar 2018.