Oncology ProblemNCT03412539
Mechanism of Effectiveness of Neurosurgery Treatments for Durable Pain
A study of Oncology Problem, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Oncology Problem
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients undergoing neurosurgical surgery for resistant pain
- Ability to sign informed consent form for participation in the study
- A functional level is sufficient for cooperation and the performance of various tasks before and after surgery, including performing MRI's, answering pain questioners, and neuropsychological evaluations.
Who cannot join
- Refusal to participate
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Patients who are candidates for procedures are referred from all over the country and undergo a multidisciplinary evaluation in the framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at the Sourasky Medical Center in Tel Aviv.
Read the detailed description
The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Patients who are candidates for procedures are referred from all over the country and undergo a multidisciplinary evaluation in the framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at the Sourasky Medical Center in Tel Aviv.
During the preoperative evaluation, patients will be given an explanation about the possibility of participating in the study. Patients who agree to participate will sign an informed consent form.
- Conditions
- Oncology Problem
- Keywords
- resistant pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology ProblemStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- University of Haifa
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412539
- Sponsor's protocol ID
- TASMC-0354-17-TLV
- Status last verified
- Jan 2018
- First submitted
- 21 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Effectiveness of Neurosurgery Treatments for Durable Pain
- ClinicalTrials.gov ID
- NCT03412539
- Acronym / sponsor ID
- TASMC-0354-17-TLV
- Conditions
- Oncology Problem
- Keywords
- resistant pain
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- University of Haifa
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Patients who are candidates for procedures are referred from all over the country and undergo a multidisciplinary evaluation in the framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at the Sourasky Medical Center in Tel Aviv.
Detailed description
The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Patients who are candidates for procedures are referred from all over the country and undergo a multidisciplinary evaluation in the framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at the Sourasky Medical Center in Tel Aviv.
During the preoperative evaluation, patients will be given an explanation about the possibility of participating in the study. Patients who agree to participate will sign an informed consent form.
Study design
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing neurosurgical surgery for resistant pain
- Ability to sign informed consent form for participation in the study
- A functional level is sufficient for cooperation and the performance of various tasks before and after surgery, including performing MRI's, answering pain questioners, and neuropsychological evaluations.
Key exclusion criteria (2 listed)
- Refusal to participate
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Oncology Problem, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ido Strauss, MD (972-3-6974949, idos@tlcmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.