Status:
UNKNOWN
Phase I Study Evaluating The Safety And Efficacy of a Device for Collection of Electrical Bioimpedance Data
Lead Sponsor:
ImpediGuide Ltd
Conditions:
Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The objectives of this study are to evaluate the safety and initial efficacy of the epidural injection procedure when combined with real-time multi-frequency bio-impedance measurements that collect da...
Eligibility Criteria
Inclusion
- Male or females 18 - 60 years of age
- Imaging spine study (CT or MRI) in previous 3 months.
- American Society of Anesthesiologists (ASA) class I-III
- Patients undergoing elective standard pain relief treatment of Epidural Steroid Injection
- Patients must be willing to participate in the study, and provide written informed consent
- Women of child bearing potential must have a negative pregnancy test during the screening and baseline visits or the patient must be surgically sterile or be at least one year postmenopausal
- Women of child-bearing potential must be using a medically acceptable method of birth control throughout the study such as: bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive that has been taken for at least three months, which the subject agrees to continue using during the study, or a double-barrier method which must consist of a combination of any two of the following: diaphragm, cervical cap, condom or spermicide.
Exclusion
- Any contraindications for epidural injection
- Patient with severe scoliosis
- Previous spinal surgery, or any additional surgical intervention in the level of epidural injection other than elective standard pain relief treatment of Epidural Steroid Injection.
- Documented, known or per examination neurological deficiency in lower extremities.
- Pregnant or breastfeeding patients
- Patients who have participated in another study within 30 days of enrolment
- Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study i.e. known coagulopathy or recent use of anticoagulants or anti aggregates.
- Presence of fever, sepsis or infection near the point of insertion or an infection in the bloodstream which may "seed" onto the catheter
- Patients with known Hypovolemia
- Any known Anatomical abnormalities, such as spina bifida, meningomyelocele or scoliosis
- Patient suffering problems of the central nervous system, including multiple sclerosis or syringomyelia
- Patients with identified heart-valve problems
- Patients excessively hirsute where the surface electrodes are to be placed that are unwilling to shave these areas.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00746915
Start Date
March 1 2009
End Date
July 1 2009
Last Update
June 5 2009
Active Locations (1)
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1
Hadassah Medical Organization, Ein Kerem
Jerusalem, Israel