NCT04593667

Brief Summary

Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2021

Completed
Last Updated

September 8, 2021

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 7, 2020

Last Update Submit

September 3, 2021

Conditions

Hemostasis

Outcome Measures

Primary Outcomes (2)

  • Time to hemostasis

    Significant change in time to hemostasis

    60 minutes

  • Compressive Force

    Change in the compressive force onto the access site

    60 minutes

Secondary Outcomes (1)

  • Radial Artery

    immediately after hemostasis

Study Arms (3)

Full Inflation

OTHER

100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder

Device: hm-P bandage

Mid Inflation

OTHER

75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder

Device: hm-P bandage

Low Inflation

OTHER

50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder

Device: hm-P bandage

Interventions

hm-P bandageDEVICE

hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.

Full InflationLow InflationMid Inflation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lenox Hill Hospital - Northwell Health

New York, New York, 10075, United States

Location

Study Officials

  • Varinder Singh, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 60 patients, randomized into one of three arms
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 20, 2020

Study Start

November 9, 2020

Primary Completion

December 9, 2020

Study Completion

July 14, 2021

Last Updated

September 8, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)