GastrectomyNCT03939819
Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy
A study testing ViSiGi® 3D suction calibration device and Esophagogastroduodenoscopy (EGD) calibration in people with Gastrectomy and Obesity, run by Emory University at 1 site in United States.
Trial summary
This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (LSG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrectomy, Obesity
- What is being tested?
- ViSiGi® 3D suction calibration device and Esophagogastroduodenoscopy (EGD) calibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 2 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice
Who cannot join
- Had prior gastric surgery or bariatric surgery (including prior adjustable gastric band and/or sleeve gastrectomy)
- Concomitant hiatal surgery
- Paraesophageal hernia at time of surgery
- Any subject with prescribed immunosuppressive drugs.
- In the opinion of investigator, subject is not eligible to participate in the study.
- If patient is a female and becomes pregnant at any time during the study duration
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital Midtown
Atlanta, Georgia, 30322
About this study
Official title: Comparison Between Endoscopic vs. Suction Calibration System on Number of Staple Load Firings, Operative Duration, Cost, and Gastro-esophageal Reflux Disease Following Laparoscopic Sleeve Gastrectomy: is There a Difference
This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (LSG).
Read the detailed description
There are multiple choices for a surgeon and their patient when it comes to weight loss surgery. One of those options is a procedure called a "laparoscopic sleeve gastrectomy" (LSG). In this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus.
During this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". They can use a standard weighted bougie, an endoscope, or a suction calibration device. This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during LSG.
- Conditions
- Gastrectomy, Obesity
- Being tested
- ViSiGi® 3D suction calibration device, Esophagogastroduodenoscopy (EGD) calibration
- Keywords
- weight loss surgery, laparoscopic sleeve gastrectomy, suction calibration system, bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViSiGi® 3D suction calibration deviceDevice
ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.
Esophagogastroduodenoscopy (EGD) calibrationDevice
Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
| Study group | Role | What they receive |
|---|---|---|
| ViSiGi® 3D suction calibration device | Experimental | The ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.
Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing. Receives: Device: ViSiGi® 3D suction calibration device |
| Esophagogastroduodenoscopy (EGD) calibration | Active comparator | Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. Receives: Device: Esophagogastroduodenoscopy (EGD) calibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Staple Load Firings
Staple usage will be recorded during the weight loss surgery procedure.
Measured: During sleeve gastrectomy (up to 5 hours)
Secondary outcomes (4)
Operative Duration (Time)
Surgery start and completion time will be recorded, and operative duration will be calculated
Measured: During sleeve gastrectomy (up to 5 hours)
Intra-operative Cost for Patients
Cost data (administrative data) will be retrieved from internal database
Measured: During sleeve gastrectomy (up to 5 hours)
GERD Symptom Severity Score
GERD-HRQL questionnaire will be administered pre-operatively and post-operatively. The instrument contains a total of 10 scaled items which are scored, and a patient-reported global satisfaction assessment which is not added to the total GERD-HRQL score. Higher score correlates with worse outcome. Scale: No symptoms = 0; Symptoms noticeable, but not bothersome = 1; Symptoms noticeable and bothersome, but not every day = 2; Symptoms bothersome every day = 3; Symptoms affect daily activities = 4; Symptoms are incapacitating, unable to do daily activities = 5
Measured: 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Body Weight
Total body weight was calculated in Kg.
Measured: 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start30 Jul 2019
- Primary completion1 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastrectomyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Hechenbleikner, Emory University
- Investigators
- Elizabeth Hechenbleikner, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939819
- Sponsor's protocol ID
- IRB00108907
- Status last verified
- May 2024
- First submitted
- 3 May 2019
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study team does not plan to make the data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Endoscopic vs. Suction Calibration System on Number of Staple Load Firings, Operative Duration, Cost, and Gastro-esophageal Reflux Disease Following Laparoscopic Sleeve Gastrectomy: is There a Difference
- ClinicalTrials.gov ID
- NCT03939819
- Acronym / sponsor ID
- IRB00108907
- Conditions
- Gastrectomy, Obesity
- Keywords
- weight loss surgery, laparoscopic sleeve gastrectomy, suction calibration system, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (LSG).
Detailed description
There are multiple choices for a surgeon and their patient when it comes to weight loss surgery. One of those options is a procedure called a "laparoscopic sleeve gastrectomy" (LSG). In this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus.
During this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". They can use a standard weighted bougie, an endoscope, or a suction calibration device. This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during LSG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViSiGi® 3D suction calibration device | Experimental | Device: ViSiGi® 3D suction calibration deviceThe ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing. |
| Esophagogastroduodenoscopy (EGD) calibration | Active comparator | Device: Esophagogastroduodenoscopy (EGD) calibrationGastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old or older
- agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice
Key exclusion criteria (6 listed)
- Had prior gastric surgery or bariatric surgery (including prior adjustable gastric band and/or sleeve gastrectomy)
- Concomitant hiatal surgery
- Paraesophageal hernia at time of surgery
- Any subject with prescribed immunosuppressive drugs.
- In the opinion of investigator, subject is not eligible to participate in the study.
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 |
|---|---|---|
| ViSiGi® 3D suction calibration deviceViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve. | Device | ViSiGi® 3D suction calibration device |
| Esophagogastroduodenoscopy (EGD) calibrationGastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy. | Device | Esophagogastroduodenoscopy (EGD) calibration |
Primary outcome
Number of Staple Load Firings
Time frame: During sleeve gastrectomy (up to 5 hours)
Staple usage will be recorded during the weight loss surgery procedure.
4 secondary outcomes
Operative Duration (Time)
Time frame: During sleeve gastrectomy (up to 5 hours)
Intra-operative Cost for Patients
Time frame: During sleeve gastrectomy (up to 5 hours)
GERD Symptom Severity Score
Time frame: 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Body Weight
Time frame: 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The study team does not plan to make the data available to other researchers.
Related trials for Gastrectomy
Active, not recruiting
Feasibility Study of Middle Segmental Gastrectomy (MSG) for Gastric Cancer.
Gastric Cancer, Gastric Adenocarcinoma
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
15-years Outcomes of Sleeve Gastrectomy on Weight Loss
Bariatric Surgery, Sleeve Gastrectomy
Not yet recruiting
De Novo Gastroesophageal Reflux Disease After Sleeve Gastrectomy With and Without Omentopexy
Omentopexy, Sleeve Gastrectomy
Recruiting
Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery
Obesity, Morbid, Obesity and Overweight
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.
Elizabeth Hechenbleikner, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViSiGi® 3D suction calibration device and Esophagogastroduodenoscopy (EGD) calibration in people with Gastrectomy and Obesity, run by Emory University at 1 site 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 2 inclusion and 6 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 21 May 2024. 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 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?
Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Staple Load Firings (time frame: During sleeve gastrectomy (up to 5 hours)). 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 21 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.