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Calibration Techniques in Sleeve Gastrectomy for Obesity

N/A
Waitlist Available
Led By Elizabeth Hechenbleikner, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Awards & highlights

Study Summary

This trial will compare the effects of two types of devices used during LSG surgery on post-operative GERD and staple usage.

Who is the study for?
This trial is for adults who have agreed with their surgeon that laparoscopic sleeve gastrectomy (LSG) is the best option for their obesity treatment. It's not open to those who've had previous gastric or bariatric surgeries, including gastric banding or sleeve gastrectomy.Check my eligibility
What is being tested?
The study compares two methods used during LSG: one group will have surgery with the help of an endoscope, and another will use a suction calibration device called ViSiGi® 3D. The focus is on how these methods affect staple usage and post-operative GERD symptoms.See study design
What are the potential side effects?
Potential side effects may include discomfort from the devices used during surgery, risks associated with general anesthesia, and typical surgical complications like infection or bleeding. Post-operative GERD symptoms are also being specifically monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Staple Load Firings
Secondary outcome measures
Change in Body Weight
Change in GERD Symptom Severity
Intra-operative Cost for Patients
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ViSiGi® 3D suction calibration deviceExperimental Treatment1 Intervention
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.
Group II: Esophagogastroduodenoscopy (EGD) calibrationActive Control1 Intervention
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,467 Total Patients Enrolled
21 Trials studying Obesity
15,616 Patients Enrolled for Obesity
Elizabeth Hechenbleikner, MDPrincipal Investigator - Emory University
Emory University Hospital, Emory University Hospital Midtown, Select Specialty Hospital-Atlanta

Media Library

Laparoscopic Sleeve Gastrectomy Clinical Trial Eligibility Overview. Trial Name: NCT03939819 — N/A
Obesity Research Study Groups: ViSiGi® 3D suction calibration device, Esophagogastroduodenoscopy (EGD) calibration
Obesity Clinical Trial 2023: Laparoscopic Sleeve Gastrectomy Highlights & Side Effects. Trial Name: NCT03939819 — N/A
Laparoscopic Sleeve Gastrectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03939819 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03939819 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this research project?

"As of February 9th 2022, this medical experiment is not currently seeking participants. Originally posted on July 30 2019, no new updates have been made in recent times. Despite that fact, there are an abundance of other clinical trials actively recruiting patients as we speak."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Emory University Hospital Midtown
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I've tried 3 other drugs that didn't work and wanted to try this trial for weight loss help.
PatientReceived no prior treatments
Because I am considered morbidly obese. I weight 350 I am down to 270. But now I use a walker to get around. I am 66 and not as active .
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does screening take?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy
Elizabeth Hechenbleikner 2019. "Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03939819.
~19 spots leftby Apr 2025
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