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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
Sponsor:
Information provided by:
ImpediGuide Ltd
ClinicalTrials.gov Identifier:
NCT00746915
First received: September 3, 2008
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Pain
Device: EpiDetect
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by ImpediGuide Ltd:

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: 20
Study Start Date: March 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: EpiDetect
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or females 18 - 60 years of age
  2. Imaging spine study (CT or MRI) in previous 3 months.
  3. American Society of Anesthesiologists (ASA) class I-III
  4. Patients undergoing elective standard pain relief treatment of Epidural Steroid Injection
  5. Patients must be willing to participate in the study, and provide written informed consent
  6. 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
  7. 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 Criteria:

  1. Any contraindications for epidural injection
  2. Patient with severe scoliosis
  3. 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.
  4. Documented, known or per examination neurological deficiency in lower extremities.
  5. Pregnant or breastfeeding patients
  6. Patients who have participated in another study within 30 days of enrolment
  7. 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.
  8. Presence of fever, sepsis or infection near the point of insertion or an infection in the bloodstream which may "seed" onto the catheter
  9. Patients with known Hypovolemia
  10. Any known Anatomical abnormalities, such as spina bifida, meningomyelocele or scoliosis
  11. Patient suffering problems of the central nervous system, including multiple sclerosis or syringomyelia
  12. Patients with identified heart-valve problems
  13. Patients excessively hirsute where the surface electrodes are to be placed that are unwilling to shave these areas.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746915

Contacts
Contact: Elyad Davidson, Dr. (+972)-2-6776911 edavidson@hadassah.org.il

Locations
Israel
Hadassah Medical Organization, Ein Kerem Recruiting
Jerusalem, Israel
Contact: Elyad Davidson, Dr    (+972)-2-6776911    edavidson@hadassah.org.il   
Principal Investigator: Elyda Davidson, Dr         
Sponsors and Collaborators
ImpediGuide Ltd
Investigators
Principal Investigator: Elyad Davidson, Dr. Hadassah Medical Oeganization, Ein Kerem
  More Information

No publications provided

Responsible Party: CEO, ImpediGuide Ltd
ClinicalTrials.gov Identifier: NCT00746915     History of Changes
Other Study ID Numbers: IG-CA001-IS
Study First Received: September 3, 2008
Last Updated: June 3, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by ImpediGuide Ltd:
Patients undergoing elective pain relief treatment of lumbar epidural steroid injection under fluoroscopy

ClinicalTrials.gov processed this record on November 20, 2014