Guided Needle Insertion for Vascular Access | NCT07548151

Studies
Guided Needle Insertion for Vascular Access

NCT07548151

Sponsor

X9, Inc.

Status

Completed

Last Update Posted

May 29, 2026Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

End Stage Renal Failure, Hemodialysis
Cannulation

Interventions

Ultrasound-Guided, Power-Assisted Needle Insertion

Countries

Uzbekistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2026Actual

Primary Completion Date

Apr 30, 2026Actual

Completion Date

Apr 30, 2026Actual

First Submitted Date

Apr 14, 2026

First Submission Date that Met QC Criteria

Apr 20, 2026

First Posted Date

Apr 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2026

Last Update Posted Date

May 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to determine whether the study device can assist the cannulator with placing two needles during cannulation required to initiate dialysis treatment.

Males or females with end-stage kidney disease who are 18 and older and not pregnant or breastfeeding can be included in the study.

The main question it aims to answer is:

Can the study device guide the cannulator to the arteriovenous fistula (AVF) or arteriovenous graft (AVG) and assist the cannulator with needle insertion into the AVF or AVG for dialysis cannulation?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound-Guided, Power-Assisted Needle Insertion	Experimental	Device Arm	Device: Ultrasound-Guided, Power-Assisted Needle Insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound-Guided, Power-Assisted Needle Insertion	Device	Device Intervention	Ultrasound-Guided, Power-Assisted Needle Insertion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of investigational device cannulations in which successful cannulation of the AVF/AVG is achieved within a maximum of three attempts, confirmed by blood flashback and ability to proceed with dialysis.		1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or non-pregnant, non-breastfeeding females ≥ 18 years of age
Presence of an AVG/AVF access site in the forearm or upper arm
AVF is actively used for dialysis treatment
AVF diameter is between 8 mm and 12mm, confirmed by ultrasound
AVF is ≤6 mm below the surface of the skin, confirmed by ultrasound
Able to report their pain using a validated pain scale.
Able and willing to provide written informed consent.

Exclusion Criteria:

Presence of known (pseudo-)aneurysms, stenosis, thrombosis or stents in the AVF/AVG access site
Presence of a condition or impediment that may interfere with ultrasound imaging

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided