Image QualityPhase 2NCT02519920
Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin
A Phase 2 study testing fluorescein sodium 0.01ml/kg, fluorescein sodium 0.02ml/kg and fluorescein sodium 0.05ml/kg in people with Image Quality and Skin Discoloration, run by Shandong University at 1 site in China.
Trial summary
This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Image Quality, Skin Discoloration
- What is being tested?
- fluorescein sodium 0.01ml/kg, fluorescein sodium 0.02ml/kg and fluorescein sodium 0.05ml/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2015
- Phase
- Phase 2
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only those with normal mucosa and minor gastritis from 18 were included.
- patients with aged 18 years to 80 years
- patients with normal mucosa and minor gastritis
- willing to provide informed consent
Who cannot join
- serious coagulopathy dysfunction, severe cardiopulmonary disease, bronchial asthma, liver and kidney dysfunction, allergy to fluorescein, pregnancy women or breast feeding.
- patients with peptic ulcer, gastric cancer, remnant stomach, acute serious gastritis were also excluded.
- unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD, PhD, 86-531-82169236 ext. 82169508, liyanqing@sdu.edu.cn
About this study
This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial.
Read the detailed description
Fluorescein sodium is one of the commonly used staining agents in confocal laser endoscopy, a device for in vivo real-time histological observation of the gastrointestinal mucosa. The conventional intravenous dosage of fluorescein sodium is in the range of 5ml to 10ml of 10% fluorescein. Image quality can be guaranteed with this range of fluorescein sodium, but yellow discoloration of the skin seriously influences daily life. This study was to test whether a lower dose of fluorescein sodium, which has minimal discoloration of skin, can provide satisfied image quality by a randomized blinded controlled trial.
- Conditions
- Image Quality, Skin Discoloration
- Being tested
- fluorescein sodium 0.01ml/kg, fluorescein sodium 0.02ml/kg, fluorescein sodium 0.05ml/kg, fluorescein sodium 0.1ml/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescein sodium 0.01ml/kgDrug
fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
fluorescein sodium 0.02ml/kgDrug
fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
fluorescein sodium 0.05ml/kgDrug
fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
fluorescein sodium 0.1ml/kgDrug
fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | This group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration. Receives: Drug: fluorescein sodium 0.01ml/kg |
| group 2 | Experimental | This group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration. Receives: Drug: fluorescein sodium 0.02ml/kg |
| group 3 | Experimental | This group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration. Receives: Drug: fluorescein sodium 0.05ml/kg |
| group 4 | Active comparator | This group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration. Receives: Drug: fluorescein sodium 0.1ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
Measured: six months
Secondary outcomes (1)
Different degrees of skin yellow dye of patients in four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Image QualityStudies 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 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD.MD, Study director, Department of Gastroenterology,Qilu Hospital,Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519920
- Sponsor's protocol ID
- 2015SDU-QILU-G08
- Status last verified
- Sep 2015
- First submitted
- 3 Aug 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin
- ClinicalTrials.gov ID
- NCT02519920
- Acronym / sponsor ID
- 2015SDU-QILU-G08
- Conditions
- Image Quality, Skin Discoloration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Aug 2015 (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.
This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial.
Detailed description
Fluorescein sodium is one of the commonly used staining agents in confocal laser endoscopy, a device for in vivo real-time histological observation of the gastrointestinal mucosa. The conventional intravenous dosage of fluorescein sodium is in the range of 5ml to 10ml of 10% fluorescein. Image quality can be guaranteed with this range of fluorescein sodium, but yellow discoloration of the skin seriously influences daily life. This study was to test whether a lower dose of fluorescein sodium, which has minimal discoloration of skin, can provide satisfied image quality by a randomized blinded controlled trial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: fluorescein sodium 0.01ml/kgThis group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration. |
| group 2 | Experimental | Drug: fluorescein sodium 0.02ml/kgThis group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration. |
| group 3 | Experimental | Drug: fluorescein sodium 0.05ml/kgThis group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration. |
| group 4 | Active comparator | Drug: fluorescein sodium 0.1ml/kgThis group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Only those with normal mucosa and minor gastritis from 18 were included.
- patients with aged 18 years to 80 years
- patients with normal mucosa and minor gastritis
- willing to provide informed consent
Key exclusion criteria (3 listed)
- serious coagulopathy dysfunction, severe cardiopulmonary disease, bronchial asthma, liver and kidney dysfunction, allergy to fluorescein, pregnancy women or breast feeding.
- patients with peptic ulcer, gastric cancer, remnant stomach, acute serious gastritis were also excluded.
- unwilling to provide informed consent
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 |
|---|---|---|
| fluorescein sodium 0.01ml/kgfluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin | Drug | group 1 |
| fluorescein sodium 0.02ml/kgfluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin | Drug | group 2 |
| fluorescein sodium 0.05ml/kgfluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin | Drug | group 3 |
| fluorescein sodium 0.1ml/kgfluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin | Drug | group 4 |
Primary outcome
Different ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
Time frame: six months
1 secondary outcome
Different degrees of skin yellow dye of patients in four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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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.
Yanqing Li, PhD.MD study director
Department of Gastroenterology,Qilu Hospital,Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorescein sodium 0.01ml/kg, fluorescein sodium 0.02ml/kg and fluorescein sodium 0.05ml/kg in people with Image Quality and Skin Discoloration, run by Shandong University at 1 site in China.
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 4 inclusion and 3 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 20 Oct 2015. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yanqing Li, PhD.MD (18678827666 ext. 82169508, qiluliyanqing@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Different ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg) (time frame: six months). It is what the study was designed to measure, not a finding.
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 20 Oct 2015.