NCT02008825

Brief Summary

We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG will:

  1. 1.enhance delineation of the stomach anatomy and the surgeon's appreciation of the extent of gastric volume to be removed;
  2. 2.increase the safety profile of the patient (i.e., reduce the likelihood of accidental stapling of the orogastric tube or bougie);
  3. 3.reduce the incidence of OR contamination/infection transmission;
  4. 4.streamline OR workflow, resulting in reduced OR time; and
  5. 5.ensure consistent and reproducible staple lines.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

November 7, 2013

Last Update Submit

December 10, 2013

Conditions

Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed;Increase the Safety Profile of the Patient (i.e., Reduce the Likelihood of Accidental Stapling of the Orogastric Tube or Bougie);Reduce the Incidence of OR Contamination/Infection Transmission;Streamline OR Workflow, Resulting in Reduced OR TimeEnsure Consistent and Reproducible Staple Lines.

Keywords

ViSiGiCalibration tubeSleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Efficasy

    This exploratory study will investigate the gastric delineation ability, general safety and efficacy of the ViSiGi™ Calibration Tube System along with the regular bougie in LSG patients over a six- to twelve-month period. Descriptive outcomes will be reported, with no formal sample size calculation in light of the exploratory study design.

    3 months

Study Arms (2)

ViSiGi

EXPERIMENTAL

Utilization of ViSiGi calibration tube

Device: Utilization of ViSiGi calibration tube

Usual standard of care

ACTIVE COMPARATOR

Usual non suction Bougie

Device: Usual non suction Bougie

Interventions

Utilization of ViSiGi calibration tubeDEVICE

Utilization of ViSiGi calibration tube

Also known as: ViSiGi 3D
ViSiGi
Usual non suction BougieDEVICE

Usual non suction Bougie

Usual standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ability to provide written informed consent for study participation.
  • age 18 years or older
  • candidate for laparosopic gastrectomy with no history of previous bariatric surgeries (i.e., gastric bypass, band, duodenal switch)attendance at an informational seminar and support group
  • clearance for surgery by a registered dietician and certified social worker
  • BMI \> 35 with at least one co-morbid condition (e.g., hypertension, diabetes mellitus, sleep apnea, hypercholesterolemia) or BMI \> 40 without any co-morbid conditions
  • negative pregnancy test
  • American Society of Anesthesiology score 1-3
  • ability to understand instructions and comply with all study requirements
  • pre-operative %excess weight loss (%EWL) of 3-10%
  • no contraindication for LSG based on upper endoscopy findings
  • pre-operative cardiac consultation for risk stratification
  • evaluation by a sleep medicine specialist to identify risk factors for sleep apnea, with treatment as deemed appropriate

You may not qualify if:

  • current participation in another clinical trial that involves any investigational drug or device that would interfere with this study
  • Barrett's Esophagus, severe gastric paresis/atony, achalasia, neoplasm or other complications discovered during preoperative esophago-gastro-duodonoscopy.
  • revisional surgery
  • conversion to open procedure
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's University and Health Network

Allentown, Pennsylvania, 18104, United States

Location

Related Publications (8)

  • Satiani B, Bonner JT, Stone HH. Factors influencing intraoperative gastric regurgitation: a prospective random study of nasogastric tube drainage. Arch Surg. 1978 Jun;113(6):721-3. doi: 10.1001/archsurg.1978.01370180063008.

    PMID: 26318BACKGROUND

  • Weiner RA, Weiner S, Pomhoff I, Jacobi C, Makarewicz W, Weigand G. Laparoscopic sleeve gastrectomy--influence of sleeve size and resected gastric volume. Obes Surg. 2007 Oct;17(10):1297-305. doi: 10.1007/s11695-007-9232-x.

    PMID: 18098398BACKGROUND

  • Abu-Gazala S, Donchin Y, Keidar A. Nasogastric tube, temperature probe, and bougie stapling during bariatric surgery: a multicenter survey. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):595-600; discussion 600-1. doi: 10.1016/j.soard.2011.08.017. Epub 2011 Aug 31.

    PMID: 21963196BACKGROUND

  • Pequignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.

    PMID: 21769286BACKGROUND

  • Sanchez BS, Safadi BY, Kieran JA, Hsu GP, Brodsky JB, Curet MJ, Morton JM. Orogastric tube complications in laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2006 Apr;16(4):443-7. doi: 10.1381/096089206776327350.

    PMID: 16608608BACKGROUND

  • Vennes JA. Infectious complications of gastrointestinal endoscopy. Dig Dis Sci. 1981 Jul;26(7 Suppl):60S-64S. doi: 10.1007/BF01300809.

    PMID: 6765053BACKGROUND

  • Kovaleva J, Peters FT, van der Mei HC, Degener JE. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev. 2013 Apr;26(2):231-54. doi: 10.1128/CMR.00085-12.

    PMID: 23554415BACKGROUND

  • Schembre DB. Infectious complications associated with gastrointestinal endoscopy. Gastrointest Endosc Clin N Am. 2000 Apr;10(2):215-32.

    PMID: 10683209BACKGROUND

Related Links

Central Study Contacts

Leonardo Claros, MD

CONTACT

4844262600Leonardo.Claros@sluhn.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bariatric Section Chief and Program Director

Study Record Dates

First Submitted

November 7, 2013

First Posted

December 11, 2013

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

US(1)