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Autonomous Blood Drawing Optimization and Performance Testing (ADOPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05878483
Recruitment Status : Recruiting
First Posted : May 26, 2023
Last Update Posted : November 1, 2023
Sponsor:
Information provided by (Responsible Party):
Vitestro B.V.

Tracking Information
First Submitted Date  ICMJE May 17, 2023
First Posted Date  ICMJE May 26, 2023
Last Update Posted Date November 1, 2023
Actual Study Start Date  ICMJE July 21, 2023
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2023)
First-time venipuncture success rate [ Time Frame: Baseline ]
Phase A/B1/B2/C1: Success is defined as blood flowing into blood tubes at first attempt; Failure is defined as no blood flowing in the blood tubes at all at first attempt. Phase C2: All blood tubes are filled sufficiently, no second venipuncture is required to obtain (all) the samples.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2023)
  • Rate of punctured participants [ Time Frame: Baseline ]
    The total number of participants that are punctured by the device is divided by the total number of included participants.
  • Rate of hemolyzed samples [ Time Frame: Baseline ]
    All samples with an (automated) hemolysis-index of >0.5 hemoglobin g/l, are classified as hemolyzed. In the laboratories where reporting occurs in umol/l, 0.5 g/l is divided by a factor: 0.5 g/l / 1.6129= 31 umol/l.
  • Adverse Events [ Time Frame: 7 days ]
    Number and type of Adverse Events (AE)s and Device Adverse Effects (ADEs) will be recorded and collected. A passive one week (7 days) follow-up occurs to determine whether any delayed adverse events occur.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autonomous Blood Drawing Optimization and Performance Testing
Official Title  ICMJE Autonomous Blood Drawing Optimization and Performance Testing
Brief Summary

The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of an autonomous blood drawing device (Venipuncture Device).

The study consists of several phases (A, B1, B2, C1, C2, 0).

Phase B1 is a confirmatory, Pivotal Clinical Study, required for regulatory approval, in which non-inferiority should be demonstrated in comparison to manual blood drawing.

Phases A, B2, C1, C2 are all exploratory studies, in which the technology and usability is further improved and tested. Phase 0 is an exploratory study for non-invasive technology testing (for example for improvement of ultrasound detection).

The study locations are outpatient blood drawing departments, in which patients are included as subjects. Additionally, in Phase A and C1, a small number of volunteers is included in a non-hospital site (Vitestro Site).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Anticipated number of participants distribution:

Phase A: 1,500 participants (max) Phase B1: 374 participants Phase B2/C1: 1,500 participants (max) Phase C2: 8,744 participants Phase 0: 1,500 participants (max)

The Phases are sequential, reflective of technology development:

Phase B1 should be completed before Phase B2/C1 can start. Phase B2 should be completed before Phase C2 can start.

Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Venipuncture
  • Phlebotomy
Intervention  ICMJE Device: Venipuncture Device (VD)

The Venipuncture Device is a pre-market medical device that fully automates the blood drawing procedure (also called phlebotomy or venipuncture). It automatically detects a vein using near-infrared and ultrasound imaging technology, robotically inserts a needle, automatically connects blood tubes and applies pressure to the puncture site.

During the ADOPT Study, the technology is further improved over time; for example features are released (such as: automated tourniquet). Initially, several manual steps are required to be performed by a device supervisor and operator. At the final stage of the ADOPT Study, Phase C2, the device has full functionality and only limited manual steps are required to be performed by a device supervisor.

Study Arms  ICMJE Experimental: Autonomous blood drawing

Hospital Sites (outpatients visiting blood drawing department):

In study Phase A1, B1, B2, C1, a subject visiting the outpatient blood drawing department will receive one automated blood draw with the Venipuncture Device. This blood draw is additional to the manual blood draw.

In study Phase C2 the automated blood draw replaces the manual blood draw. In Phase C2, the subject might therefore receive two automated blood draws, in case a redraw is required.

Vitestro Site (volunteers):

In study Phase A, C1 volunteers visit Vitestro Site. Participants receive one to two automated blood draws.

Intervention: Device: Venipuncture Device (VD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2023)
13618
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

• Age ≥16 years.

Exclusion Criteria:

  • Unable to follow instructions, due to mental disability and/or incapacity
  • Unable to use device correctly due to physical impairment or disability (for example a patient with severe contractures or deformities)
  • No venipuncture possible in cubital fossa of both arms (for example: after amputation of both arms)
  • No venipuncture possible in cubital fossa due to contra-indications in both arms (for example: tattoos in both arms)
  • Incapacitated persons
  • Pregnant or breast-feeding

The following contra-indications / exclusion criteria are respected per arm:

  • Arteriovenous fistula or vascular graft
  • Paretic or paralyzed arm (e.g. after stroke or trauma)
  • Infected skin in cubital fossa (for example: erysipelas or cellulitis)
  • Mastectomy side, axillary lymph node excised
  • Healed skin burns in cubital fossa
  • Edema in cubital fossa
  • Extensive scarring in cubital fossa
  • Hematoma in cubital fossa
  • Tattoos in cubital fossa

In case the test subject has a suitable contralateral arm, the subject can be included in this study. In Study Phase B2, a manual venipuncture and automated venipuncture are performed in both arms. Patients who have a contra-indication in one arm are excluded from the Phase B2 study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Luuk Giesen, MD +31 30 200 45 51 luuk.giesen@vitestro.com
Contact: Jeroen Roest, MSc +31 30 200 45 51 jeroen.roest@vitestro.com
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05878483
Other Study ID Numbers  ICMJE NL80965.000.22
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Vitestro B.V.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vitestro B.V.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luuk Giesen, MD Vitestro B.V.
PRS Account Vitestro B.V.
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP