← Back to Search

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Staple Load Firings

Secondary study objectives

Body Weight

GERD Symptom Severity Score

Intra-operative Cost for Patients

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ViSiGi® 3D suction calibration device

2019

N/A

~110

Do I qualify?Apply below to find out