EGDS Preparation; Fasting; LumevisNCT05401383
Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis
An observational study of EGDS Preparation; Fasting; Lumevis, run by Azienda USL Modena at 1 site in Italy.
Trial summary
One of the major problems for the endoscopist during esophagogastroduodenoscopy (EGDS) is the presence of foam, bubbles, mucus and saliva, whether small or large, which can compromise correct endoscopic visibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- EGDS Preparation; Fasting; Lumevis
- What is being tested?
- Lumevis (IIa class)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 31 Mar 2023
- 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: adult patients who had to perform EGDS
Who may be able to join
- adult patients that underwent EGDS
Who cannot join
- previous upper GI surgery
- previous endoscopic bariatric procedures
- known upper GI stenosis (benign and malign)
- previous diagnosis of achalasia or motility disorders
- diabetes
- allergy to one of lumevis components
Show all 12Show fewer
- cystinuria
- fasting not correctly respected
- pregnant or brest-feeding women
- urgent-emercengy setting
- inpatients
- patients who don't give their consent to partecipate to the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Upper Gi Endoscopy Preparation: RCT Fasting Versus Lumevis
One of the major problems for the endoscopist during esophagogastroduodenoscopy (EGDS) is the presence of foam, bubbles, mucus and saliva, whether small or large, which can compromise correct endoscopic visibility. Endoscopy of the upper gastrointestinal tract, like that of the lower gastrointestinal tract, requires optimal visualization of the mucosa. It is clear that endoscopic vision is often hindered by the presence of bubbles and foam: multiple aspirations alternating with intraprocedural washes are therefore necessary, which lengthen the time necessary for the endoscopic examination. Nowadays there's no universal raccomandation about a specific preparation before EGDS.
The aim of our study is to compare fasting versus the use of simethicone premedication in combination with N-acetyl- cysteine and acetic acid (LumevisTM).
Read more
The study is observational, randomized 1:1, and double blind. Primary outcomes are: grade of mucosa visualization defined by visual analogue scale (0-10) for each analyzed segment (esophagus, stomach and duodenum).
Secondary aims: general patient satisfaction defined by visual analogue scale, eventual adverse events, duration of the exam.
- Conditions
- EGDS Preparation; Fasting; Lumevis
- Being tested
- Lumevis (IIa class)
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumevis (IIa class)Device
intake of Lumevis 30 minutes before EGDS
| Study group | Role | What they receive |
|---|---|---|
| Group A | fasting from solids (6 hours before) and clear fluids (2 hours before the exam) | |
| Group B | Lumevis intake (50 ml), 30 minutes before the exam plus fasting as group A Receives: Device: Lumevis (IIa class) |
What is being measured
The primary outcome is the main question the study is designed to answer.
grade of mucosa visibility
evalueted by VAS after the exam (it will be recorded a video) by a physician that not performed the exam and that are blinded about the randomization
Measured: 6 months
Secondary outcomes (3)
general patient satisfaction
evalueted by VAS at the end of the exam, before the discharge to home
Measured: 6 months
eventual adverse events
evalueted by ASGE lexicon, at the end of the exam, before the discharge to home
Measured: 6 months
duration of the exam
minutes between intubation and extubation of the endoscope from the mouth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Dec 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGDS Preparation; Fasting; LumevisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mauro Manno, Azienda USL Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401383
- Sponsor's protocol ID
- AziendaUSLModena
- Status last verified
- May 2022
- First submitted
- 27 May 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Upper Gi Endoscopy Preparation: RCT Fasting Versus Lumevis
- ClinicalTrials.gov ID
- NCT05401383
- Acronym / sponsor ID
- AziendaUSLModena
- Conditions
- EGDS Preparation; Fasting; Lumevis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda USL ModenaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
One of the major problems for the endoscopist during esophagogastroduodenoscopy (EGDS) is the presence of foam, bubbles, mucus and saliva, whether small or large, which can compromise correct endoscopic visibility. Endoscopy of the upper gastrointestinal tract, like that of the lower gastrointestinal tract, requires optimal visualization of the mucosa. It is clear that endoscopic vision is often hindered by the presence of bubbles and foam: multiple aspirations alternating with intraprocedural washes are therefore necessary, which lengthen the time necessary for the endoscopic examination. Nowadays there's no universal raccomandation about a specific preparation before EGDS.
The aim of our study is to compare fasting versus the use of simethicone premedication in combination with N-acetyl- cysteine and acetic acid (LumevisTM).
The study is observational, randomized 1:1, and double blind. Primary outcomes are: grade of mucosa visualization defined by visual analogue scale (0-10) for each analyzed segment (esophagus, stomach and duodenum).
Secondary aims: general patient satisfaction defined by visual analogue scale, eventual adverse events, duration of the exam.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –fasting from solids (6 hours before) and clear fluids (2 hours before the exam) |
| Group B | – | Device: Lumevis (IIa class)Lumevis intake (50 ml), 30 minutes before the exam plus fasting as group A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who had to perform EGDS
Key inclusion criteria (1 listed)
- adult patients that underwent EGDS
Key exclusion criteria (12 listed)
- previous upper GI surgery
- previous endoscopic bariatric procedures
- known upper GI stenosis (benign and malign)
- previous diagnosis of achalasia or motility disorders
- diabetes
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 |
|---|---|---|
| Lumevis (IIa class)intake of Lumevis 30 minutes before EGDS | Device | Group B |
Primary outcome
grade of mucosa visibility
Time frame: 6 months
evalueted by VAS after the exam (it will be recorded a video) by a physician that not performed the exam and that are blinded about the randomization
3 secondary outcomes
general patient satisfaction
Time frame: 6 months
eventual adverse events
Time frame: 6 months
duration of the exam
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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 EGDS Preparation; Fasting; Lumevis, run by Azienda USL Modena at 1 site in Italy.
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 12 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 6 Feb 2023. 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 Italy. 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 Mauro Manno (0039 059659250, m.manno@ausl.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade of mucosa visibility (time frame: 6 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 6 Feb 2023.