Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

NCT03939819 | Completed Results DMC FDA Device

• 1 other identifier: IRB00108907
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gastrectomy; Obesity

Keywords

weight loss surgery; laparoscopic sleeve gastrectomy; suction calibration system; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Number of Staple Load Firings

  Staple usage will be recorded during the weight loss surgery procedure.

  During sleeve gastrectomy (up to 5 hours)

Secondary Outcomes (4)

• Operative Duration (Time)

  During sleeve gastrectomy (up to 5 hours)

• Intra-operative Cost for Patients

  During sleeve gastrectomy (up to 5 hours)

• GERD Symptom Severity Score

  1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)

• Body Weight

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

Study Arms (2)

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.

Device: ViSiGi® 3D suction calibration device

Esophagogastroduodenoscopy (EGD) calibration

ACTIVE COMPARATOR

Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.

Device: Esophagogastroduodenoscopy (EGD) calibration

Interventions

ViSiGi® 3D suction calibration device DEVICE

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.

ViSiGi® 3D suction calibration device

Esophagogastroduodenoscopy (EGD) calibration DEVICE

Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.

Esophagogastroduodenoscopy (EGD) calibration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital Midtown

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Endoscopy, Digestive System; Calibration

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Weights and Measures; Investigative Techniques

Results Point of Contact

• Title: Dr. Elizabeth Hechenbleikner
• Organization: Emory University

elizabeth.hechenbleikner@emory.edu

404-778-3712

Study Officials

• Elizabeth Hechenbleikner, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 7, 2019
• Study Start: July 30, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 2, 2022
• Last Updated: May 21, 2024
• Results First Posted: March 7, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)