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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04457427
Other study ID # CLIN 20-1000-35
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date March 2022

Study information

Verified date March 2020
Source Synapse Biomedical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.


Description:

15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days

- Signed written informed consent has been obtained prior to performing any study related procedure(s)

- Subject is at least 18 years of age

- Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)

Exclusion Criteria:

- Diaphragm malformation which makes electrode insertion impossible

- Presence of an implantable cardioverter-defibrillator

- Severe chronic obstructive pulmonary disease (COPD)

- Subject is pregnant or breastfeeding

- Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy

- Terminal patients expected to die during their stay in the hospital

- Participation in other clinical studies that could interfere with the results in the ongoing study

Study Design


Intervention

Device:
NeuRx Diaphragm Pacing System (DPS)
4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity.

Locations

Country Name City State
Turkey Marmara Univeristy Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Synapse Biomedical

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Electrode removal (3) Safe and complete removal of electrodes prior to discharge from the hospital or thirty (30) days, whichever occurs first Through study completion, an average of 6 years
Primary Device and procedure safety Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first Through study completion, an average of 6 years
Primary Monitoring Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction Through study completion, an average of 6 years
Primary Stimulation Increase in magnitude of diaphragm burst activity with stimulation Through study completion, an average of 6 years
Secondary Effects of diaphragm stimulation Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay Through study completion, an average of 6 years
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