Trial Outcomes & Findings for Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices (NCT NCT01312519)

Last Updated: 2013-08-07

Results Overview

Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Day 1 during the needle insertion

Results posted on

2013-08-07

Participant Flow

Adult patients 18 years of age requiring bone marrow aspiration and biopsy as part of routine care were considered eligible for the study.

No pre-assisgnment details.

Participant milestones

Participant milestones
Measure	Manual Bone Marrow Sampling Device hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.	OnControl Bone Marrow System Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
Overall Study STARTED	26	24
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Manual Bone Marrow Sampling Device n=26 Participants Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.	OnControl Bone Marrow System n=24 Participants Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Age Continuous	59 years STANDARD_DEVIATION 17 • n=5 Participants	53 years STANDARD_DEVIATION 19.0 • n=7 Participants	56.0 years STANDARD_DEVIATION 18.0 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	18 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Spain	14 participants n=5 Participants	6 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 during the needle insertion

Population: as per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.

Outcome measures

Outcome measures
Measure	Manual Bone Marrow Sampling Device n=26 Participants hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.	OnControl Bone Marrow System n=24 Participants Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
Subject Reported Level of Pain During Procedure	3.8 units on a scale Standard Deviation 3.0	3.2 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Day 1 needle insertion through needle removal

Population: Per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.

The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.

Outcome measures

Outcome measures
Measure	Manual Bone Marrow Sampling Device n=26 Participants hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.	OnControl Bone Marrow System n=24 Participants Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
Time Necessary to Perform the Bone Marrow Procedure	224.1 seconds Standard Deviation 79.0	100.0 seconds Standard Deviation 72.8

Adverse Events

Manual Bone Marrow Sampling Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OnControl Bone Marrow System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Director of Science and Clinical

Vidacare Corporation

Phone: 210-375-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60