EGD ProcedureNCT04621591
Case Series With Saneso 360° Gastroscope
A study testing Saneso 360° gastroscope in people with EGD Procedure, run by Saneso Inc. at 6 sites in United States.
Trial summary
To confirm the procedural performance of the Saneso 360° gastroscope in Esophago-gastro-duodenoscopy (EGD) procedures. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- EGD Procedure
- What is being tested?
- Saneso 360° gastroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Aug 2020to 9 Sep 2020
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 -74 years of age
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- Scheduled for a clinically indicated routine EGD procedure
- ASA class 1-3.
Who cannot join
- Altered esophageal, gastric, or duodenal anatomy
- Pregnant women, children under 18 years of age, and adults over 75 years of age.
- Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.
- Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
- ASA class 4-5.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
West Virginia University School of Medicine - Davis Medical Center
Elkins, West Virginia, 26241
West Virginia University School of Medicine - Reynolds Memorial Hospital
Glendale, West Virginia, 26038
West Virginia University School of Medicine - Reynolds Memorial Hospital,
Glendale, West Virginia, 26506
Valley Endoscopy Center
Saint Clairsville, Ohio, 43950
West Virginia University School of Medicine - Wheeling Hospital
Wheeling, West Virginia, 26003
Wintersville Endoscopy Center, Wintersville
Wintersville, Ohio, 43953
About this study
Official title: Case Series With Saneso 3600 Gastroscope
To confirm the procedural performance of the Saneso 360° gastroscope in Esophago-gastro-duodenoscopy (EGD) procedures.
Read the detailed description
This study is a prospective, multicenter case series per standard of care EGD procedures using a nonsignificant risk Saneso 360° gastroscope. 20 cases will be included at up to five (5) clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated EGD procedure performed using the study device. Immediately thereafter, patients will have an EGD procedure using a standard Gastroscope (Olympus GIF180) by a second endoscopist. Enrolled subjects will be followed for 7 days after their procedure. If the procedure is not successful with the study device, the endoscopist will complete the procedure with a traditional gastroscope used at each facility.
- Conditions
- EGD Procedure
- Being tested
- Saneso 360° gastroscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saneso 360° gastroscopeDevice
Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.
| Study group | Role | What they receive |
|---|---|---|
| Saneso 360° gastroscope | Experimental | Subjects will have a clinically indicated per standard of care EGD procedure performed using the Saneso 360° gastroscope. Immediately thereafter Patients will then have an EGD procedure using a standard Gastroscope (Olympus GIF 180) performed by a second endoscopist. Receives: Device: Saneso 360° gastroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful EGD
Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken.
Measured: Within 24 hours on study day
Secondary outcomes (4)
Endoscopist qualitative rating of the Saneso 360° gastroscope
Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable).
Measured: Within 24 hours on study day
Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG)
Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG).
Measured: Within 7 days of completion of the study
Evaluation of adverse events (AEs) related to the device.
AEs are assessed through 7 days after the procedure.
Measured: Within 7 days of completion of the study
Evaluation of any potential mucosal injury
Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear).
Measured: Immediately after the use of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Aug 2020
- Primary completion30 Aug 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGD ProcedureStudies 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saneso Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West Virginia University
- Responsible party
- Sponsor
- Investigators
- George Goetz, M.D; Ph.D., Principal investigator, West Virginia School of Medicine, Morgantown, WV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621591
- Sponsor's protocol ID
- SAN360UGICL
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Series With Saneso 3600 Gastroscope
- ClinicalTrials.gov ID
- NCT04621591
- Acronym / sponsor ID
- SAN360UGICL
- Conditions
- EGD Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Saneso Inc.Industry (pharma, biotech, devices)
- Collaborators
- West Virginia University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 9 Nov 2020 (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.
To confirm the procedural performance of the Saneso 360° gastroscope in Esophago-gastro-duodenoscopy (EGD) procedures.
Detailed description
This study is a prospective, multicenter case series per standard of care EGD procedures using a nonsignificant risk Saneso 360° gastroscope. 20 cases will be included at up to five (5) clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated EGD procedure performed using the study device. Immediately thereafter, patients will have an EGD procedure using a standard Gastroscope (Olympus GIF180) by a second endoscopist. Enrolled subjects will be followed for 7 days after their procedure. If the procedure is not successful with the study device, the endoscopist will complete the procedure with a traditional gastroscope used at each facility.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saneso 360° gastroscope | Experimental | Device: Saneso 360° gastroscopeSubjects will have a clinically indicated per standard of care EGD procedure performed using the Saneso 360° gastroscope. Immediately thereafter Patients will then have an EGD procedure using a standard Gastroscope (Olympus GIF 180) performed by a second endoscopist. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 -74 years of age
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- Scheduled for a clinically indicated routine EGD procedure
- ASA class 1-3.
Key exclusion criteria (5 listed)
- Altered esophageal, gastric, or duodenal anatomy
- Pregnant women, children under 18 years of age, and adults over 75 years of age.
- Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.
- Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
- ASA class 4-5.
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 |
|---|---|---|
| Saneso 360° gastroscopeSubjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope. | Device | Saneso 360° gastroscope |
Primary outcome
Successful EGD
Time frame: Within 24 hours on study day
Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken.
4 secondary outcomes
Endoscopist qualitative rating of the Saneso 360° gastroscope
Time frame: Within 24 hours on study day
Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG)
Time frame: Within 7 days of completion of the study
Evaluation of adverse events (AEs) related to the device.
Time frame: Within 7 days of completion of the study
Evaluation of any potential mucosal injury
Time frame: Immediately after the use of the device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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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.
George Goetz, M.D; Ph.D. principal investigator
West Virginia School of Medicine, Morgantown, WV
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saneso 360° gastroscope in people with EGD Procedure, run by Saneso Inc. at 6 sites in United States.
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 5 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: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful EGD (time frame: Within 24 hours on study day). 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 10 Nov 2020.