Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04930237 |
Other study ID # |
013.MBSI.2021.D |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2021 |
Est. completion date |
April 22, 2022 |
Study information
Verified date |
April 2022 |
Source |
Methodist Health System |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This will be a prospective case-control study of 40 patients undergoing 1-2 level ALIF
procedures at Methodist Dallas Medical Center (MDMC). Patient records will be reviewed to
identify details including demographics, comorbidities, procedure details, and the primary
and secondary outcome metrics.
Description:
RELISTOR is a legally marketed device and will be used off-label under the authority of a
health care practitioner within a legitimate practitioner-patient relationship with the
intent of the "practice of medicine".
The use of RELISTOR in the experimental group of this study meets all of the following
conditions:
- is not intended to be reported to the FDA in support of a new indication for use or to
support any other significant change in the labeling for the drug;
- it is not intended to support a significant change in the advertising for the product;
- it does not involve a route of administration or dosage level, use in a subject
population, or other factor that significantly increases the risks (or decreases the
acceptability of the risks) associated with the use of the drug product;
- it is conducted in compliance with the requirements for IRB review and informed consent
[21 CFR parts 56 and 50, respectively];
- it is conducted in compliance with the requirements concerning the promotion and sale of
drugs [21 CFR 312.7]; and
- it does not intend to invoke 21 CFR 50.24
Screening and Enrollment:
Patients will undergo two levels of screening: the initial screening and a post-operative OIC
screening. The initial screening will involve all 1-2 level ALIF patients in the experimental
group and observational group who will be approached to participate in the study before
surgery. After eligible patients agree to participate and sign the ICF, all patients will
then be asked to complete the PAC-SYM instrument about their constipation symptoms over the
past 2 weeks.
Patients in both groups will undergo their 1-2 level ALIF procedure and then will undergo the
post-operative OIC screen/rescreen (as needed) daily for acute OIC for a maximum of 3 days
(i.e., postoperative days 2 - 4). Patients who are found to have acute OIC will be designated
to the experimental and observational treatment regimens accordingly to Study Treatment
Regimens.
If a patient does not have acute OIC after they are rescreened on postoperative day 4, are
discharged, or do not meet the inclusion criteria, will be placed in the not-constipated or
post-operative screen failure group.