A Study of a Device That Helps Place Dialysis Needles
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorX9, Inc.
About this trial
The purpose of this study is to evaluate the safety and effectiveness of the X9 Ultrasound System with Power-Assisted Needle Insertion, an investigational device, compared with standard of care (SOC) cannulation for placing haemodialysis needles in an arteriovenous fistula (AVF) or arteriovenous graft (AVG).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or non-pregnant, non-breastfeeding females ≥ 21 years of age
Receiving facility-based (in-center) haemodialysis
Presence of an arteriovenous fistula (AVF) or arteriovenous graft (AVG) in the arm.
AVF/AVG is actively used for haemodialysis treatment.
Disqualifiers
Presence of known stents in the cannulation zone of the AVF/AVG access site
Presence of a condition or impediment that may interfere with ultrasound imaging
Trial design
Design model
Crossover
Treatments tested in this trial
Needle placement with the Investigational Device
DeviceDialysis cannulation needle placement with the investigational device
Needle Placement with SOC
Other interventionDialysis cannulation needle placement per SOC
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Standard of Care CannulationActive comparator 1 intervention
Group B: Investigational Device CannulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cannulation Clinical Success Score (CCSS)
Co-primary endpoint. CCSS is achieved when haemodialysis is successfully started without additional needle puncture, needle repositioning or redirection, or infiltration. For each participant, the number of sessions achieving CCSS (out of three per treatment condition) is compared between the investigational device and standard of care (SOC). The study meets its primary effectiveness criterion only if both co-primary endpoints (CCSS and pain) are met.
Time frame
At each of six cannulation sessions over 2 weeks2
Mean Insertion Pain (0-10 Numeric Rating Scale)
Co-primary endpoint. Participants rate pain for each needle insertion on a 0-10 scale (0 = no pain, 10 = worst pain possible). Each participant's mean pain score with the investigational device is compared with their mean pain score with SOC. The study meets its primary effectiveness criterion only if both co-primary endpoints (CCSS and pain) are met.
Time frame
At each of six cannulation sessions over 2 weeks3
Rate of serious adverse events (SAEs) related to the investigational device or procedure during the clinical investigation.
Each participant will be a safety endpoint failure if the participant has SAEs related to the investigational device or procedure, otherwise the participant will be a primary safety endpoint success.
Time frame
At each of three investigational device cannulation sessions over 1 weekSecondary outcomes
1
Cannulation Clinical Success Score (CCSS): Superiority
Superiority of the investigational device to SOC for the number of sessions achieving CCSS. Tested only if both co-primary endpoints (CCSS and pain) are met. Not required for the primary effectiveness endpoint.
Time frame
At each of six cannulation sessions over 2 weeks2
Technical insertion success with blood flashback
The proportion of sessions in each group with successful blood flashback from both needles.
Time frame
At each of six cannulation sessions over 2 weeks3
Successful initiation of hemodialysis
The proportion of sessions in each group with successful initiation of hemodialysis.
Time frame
At each of six cannulation sessions over 2 weeks4
Successful completion of hemodialysis
The proportion of sessions in each group with successful completion of hemodialysis.
Time frame
At each of six cannulation sessions over 2 weeks Source ClinicalTrials.gov
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