Colon CarcinomaNCT00996619
Measuring the Spectrum of Tissues During Endoscopy
An observational study of Colon Carcinoma and Colonic Polyps, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different composition compared to the normal mucose. The investigators plan to gather spectroscopic information from these features. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Carcinoma, Colonic Polyps, Intestinal Polyps
- What is being tested?
- An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to May 2010
- Phase
- Observational
- 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
Study population: Independent Adults
Who may be able to join
- Adult, independent patients who come to Sheba Hospital's gastro-intestinal clinic for endoscopy and are willing to sign an informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Tel HaShomer, 52621
Gidi Arbel, Dr., +97235305260, gidi.arbel@sheba.health.gov.il
Gidi Arbel, Dr.
About this study
Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different composition compared to the normal mucose. The investigators plan to gather spectroscopic information from these features. Characterizing their unique spectrums, may help to enhance the detection and identification of these objects during endoscopy.
- Conditions
- Colon Carcinoma, Colonic Polyps, Intestinal Polyps
- Being tested
- An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps, Intestinal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examinationProcedure or surgery
Also called The brand of the optical fiber is not relevant
An optical fiber, inside the work channel of an endoscope, connected to a spectroscope, enables measuring the spectrum of objects "seen" by the endoscope
| Study group | Role | What they receive |
|---|---|---|
| People undergoing GI tract endoscopy | Not described Receives: Procedure: An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CarcinomaStudies of the same condition, open and under way.
- More trials run by Sheba 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996619
- Sponsor's protocol ID
- SHEBA-7285-09-AO-CTIL
- Status last verified
- Oct 2009
- First submitted
- 29 Sep 2009
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Spectrum of Tissues During Endoscopy
- ClinicalTrials.gov ID
- NCT00996619
- Acronym / sponsor ID
- SHEBA-7285-09-AO-CTIL
- Conditions
- Colon Carcinoma, Colonic Polyps, Intestinal Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 16 Oct 2009 (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.
Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different composition compared to the normal mucose. The investigators plan to gather spectroscopic information from these features. Characterizing their unique spectrums, may help to enhance the detection and identification of these objects during endoscopy.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People undergoing GI tract endoscopy | – | Procedure: An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Independent Adults
Key inclusion criteria (1 listed)
- Adult, independent patients who come to Sheba Hospital's gastro-intestinal clinic for endoscopy and are willing to sign an informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| An optical fiber, inside the work channel of an endoscope, is added to the endoscopic examinationAlso: The brand of the optical fiber is not relevantAn optical fiber, inside the work channel of an endoscope, connected to a spectroscope, enables measuring the spectrum of objects "seen" by the endoscope | Procedure or surgery | People undergoing GI tract endoscopy |
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 16 Oct 2009.
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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?
An observational study of Colon Carcinoma and Colonic Polyps, run by Sheba 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 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 16 Oct 2009. 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 Arie Orenshtein, Prof. (+97235303114, Arie.Orenstein@sheba.health.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 16 Oct 2009.