Phase I Study Evaluating The Safety And Efficacy of a Device for Collection of Electrical Bioimpedance Data
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by ImpediGuide Ltd.
Recruitment status was Recruiting
Information provided by:
First received: September 3, 2008
Last updated: June 3, 2009
Last verified: June 2009
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 data on the electrical bioimpedance characteristics of living human tissue on the path of the epidural needle.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Prospective, Single-Center, Phase I Study Evaluating the Safety and Initial Efficacy of the Epidetect Device for Collection of Bioimpedance Data of Human Tissues in Patients Undergoing Elective Pain Relief Treatment of Lumbar Epidural Steroid Injection Under Fluoroscopy
Primary Outcome Measures:
- Safety variables collected will include the incidence of adverse events presented by severity, by seriousness and by relationship to study treatment [ Time Frame: 2 weeks and 1 month post op ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Obtaining real-time bioimpedance measurements in multiple frequencies within the range of 1kHz to 500kHz from human tissues crossed in the epidural needle path. [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2009 (Final data collection date for primary outcome measure)
During the epidural needle insertion, data will be collected to characterize in real-time the electrical bioimpedance properties of the types of tissue along the path of the needle.
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746915
|Hadassah Medical Organization, Ein Kerem
|Jerusalem, Israel |
|Contact: Elyad Davidson, Dr (+972)-2-6776911 firstname.lastname@example.org |
|Principal Investigator: Elyda Davidson, Dr |
||Elyad Davidson, Dr.
||Hadassah Medical Oeganization, Ein Kerem
No publications provided
||CEO, ImpediGuide Ltd
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 3, 2008
||June 3, 2009
||Israel: Ministry of Health
Keywords provided by ImpediGuide Ltd:
ClinicalTrials.gov processed this record on April 17, 2014
Patients undergoing elective pain relief treatment of lumbar epidural steroid injection under fluoroscopy