NCT02679118

Brief Summary

This study will determine the ability of the device to draw a small amount of gas from an insufflated abdomen during laparoscopic surgery and accurately detect if gaseous content from the bowel is present.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

February 4, 2016

Last Update Submit

August 15, 2017

Conditions

Intestinal Perforation

Keywords

intestinal perforationbariatric surgerygastric bypassgastric perforationcolonic perforation

Outcome Measures

Primary Outcomes (2)

  • Methane levels released in the abdominal cavity from small bowel

    Ability to detect and measure the level of methane released in the abdominal cavity by open small bowel

    Intra-operative measurement only

  • Hydrogen levels released in the abdominal cavity from small bowel

    Ability to detect and measure the level of hydrogen released in the abdominal cavity by open small bowel

    Intra-operative measurement only

Study Arms (1)

Sentire

EXPERIMENTAL

The patients will undergo their laparoscopic gastric bypass, during the operative period at pre-defined time points, a small amount of gas from the abdomen will be withdrawn and analyzed for the device. The laparoscopic gastric bypass will proceed without interference or effect from the device.

Device: Sentire

Interventions

SentireDEVICE

The device, at predetermined time points, will draw a small amount of gas from the abdomen. Upon obtaining the samples, the machine will analyze the sample for evidence of bowel gas. After each sample, the device will be purged prior to the acquisition of the next gas sample. The results of the analysis of the gas samples will be recorded for future analysis.

Sentire

Eligibility Criteria

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

You may qualify if:

  • Age 18 - 60 years old with the diagnosis of morbid obesity, who qualifies for laparoscopic gastric bypass surgical therapy, and has elected to undergo laparoscopic gastric bypass surgery.
  • Receiving care in the Stanford Hospital General Surgery Bariatric Surgery Clinic under the care of Dr. Dan Azagury
  • The patient is scheduled for laparoscopic roux en y gastric bypass surgery, with Dr. Azagury.
  • Willing and cognitively able to sign informed consent.

You may not qualify if:

  • Lack of or inability to provide informed consent.
  • Less than 18 years of age or greater than 60 years of age
  • Planned deviation from the standard laparoscopic gastric bypass operation
  • Conversion intra-operatively from a laparoscopic gastric bypass to an alternative laparoscopic surgical operation or to an open gastric bypass operation.
  • Enrollment in another device or drug study that may confound results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (3)

  • Deffieux X, Ballester M, Collinet P, Fauconnier A, Pierre F; French National College of Gynaecologists and Obstetricians. Risks associated with laparoscopic entry: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):159-66. doi: 10.1016/j.ejogrb.2011.04.047. Epub 2011 May 31.

    PMID: 21621318BACKGROUND

  • Sahakian AB, Jee SR, Pimentel M. Methane and the gastrointestinal tract. Dig Dis Sci. 2010 Aug;55(8):2135-43. doi: 10.1007/s10620-009-1012-0. Epub 2009 Oct 15.

    PMID: 19830557BACKGROUND

  • van der Voort M, Heijnsdijk EA, Gouma DJ. Bowel injury as a complication of laparoscopy. Br J Surg. 2004 Oct;91(10):1253-8. doi: 10.1002/bjs.4716.

    PMID: 15376204BACKGROUND

MeSH Terms

Conditions

Intestinal Perforation

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Dan Azagury, MD

    Assistant Professor of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 10, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)