Oxidative StressNCT01393587
A New Exogenous Marker for Diagnosis of Oxidative Stress During Laproscopic Surgery
A study testing Taking blood samples in people with Oxidative Stress and Laproscopy, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Recently, a new synthetic marker was developed, based on a molecule that is composed of Amino Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor changes of oxidative stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Laproscopy
- What is being tested?
- Taking blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients undergoing elective laproscopic cholecystectomy and patients undergoing operation for tumer of large intenstine.
Who cannot join
- Patients suffering from Cardio Pulmonory and renal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Recently, a new synthetic marker was developed, based on a molecule that is composed of Amino Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor changes of oxidative stress.
The investigators would like to assess the usefulness of this marker during positive pressure pneumoperitoneum, during laproscopic surgery, with or without intenstinal resection (ischemia induced by intra-abdominal pressure and vascualr compromise).
- Conditions
- Oxidative Stress, Laproscopy
- Being tested
- Taking blood samples
- Keywords
- Oxidative Stress, Laproscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking blood samplesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Procedure: Taking blood samples |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Collaborators
- Migal, Galilee Technology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393587
- Sponsor's protocol ID
- BIC-2011
- Status last verified
- Jul 2011
- First submitted
- 12 Jul 2011
- Last updated
- 18 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Exogenous Marker for Diagnosis of Oxidative Stress During Laproscopic Surgery
- ClinicalTrials.gov ID
- NCT01393587
- Acronym / sponsor ID
- BIC-2011
- Conditions
- Oxidative Stress, Laproscopy
- Keywords
- Oxidative Stress, Laproscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Collaborators
- Migal, Galilee Technology Center
- First posted
- 13 Jul 2011 (estimated)
- 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.
Recently, a new synthetic marker was developed, based on a molecule that is composed of Amino Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor changes of oxidative stress.
The investigators would like to assess the usefulness of this marker during positive pressure pneumoperitoneum, during laproscopic surgery, with or without intenstinal resection (ischemia induced by intra-abdominal pressure and vascualr compromise).
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Taking blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy patients undergoing elective laproscopic cholecystectomy and patients undergoing operation for tumer of large intenstine.
Key exclusion criteria (1 listed)
- Patients suffering from Cardio Pulmonory and renal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taking blood samples | Procedure or surgery | Experimental |
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 18 Jul 2012.
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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 testing Taking blood samples in people with Oxidative Stress and Laproscopy, run by Western Galilee Hospital-Nahariya 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 1 inclusion and 1 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 18 Jul 2012. 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 Amitai Bickel, Dr. (+972-507887554 ext. 7554, amitai@netvision.net.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 18 Jul 2012.