Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed;Phase 1ViSiGiNCT02008825
Evaluation of the ViSiGiTM Calibration System
A Phase 1 study testing Utilization of ViSiGi calibration tube and Usual non suction Bougie in people with Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed; and Increase the Safety Profile of the Patient (i.e., Reduce the Likelihood of Accidental Stapling of the Orogastric Tube or Bougie);, run by St. Luke's Hospital and Health Network, Pennsylvania at 1 site in United States.
Trial summary
We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG will: 1. enhance delineation of the stomach anatomy and the surgeon's appreciation of the extent of gastric volume to be removed; 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 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;
- What is being tested?
- Utilization of ViSiGi calibration tube and Usual non suction Bougie
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's University and Health Network
Allentown, Pennsylvania, 18104
Leonardo Claros, 484-426-2600, Leonardo.Claros@sluhn.org
Leonardo Claros, MD
About this study
Official title: Evaluation of the ViSiGiTM Calibration System for Effectiveness With Sleeve Visual Delineation at Various Suction Levels.
We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG will:
- 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 time; and
- ensure consistent and reproducible staple lines.
Read the detailed description
Laparoscopic Sleeve Gastrectomy (LSG), is now widely used as a stand-alone procedure for long-term weight loss. With fewer potential morbidities, comparable weight loss and greater ease of conversion to other procedures, many patients now opt for LSG as their bariatric procedure of choice. During surgery gastric decompression and calibration are compulsory for patient safety, gastric anatomic delineation, ease of surgery and optimal weight loss. The removed gastric volume at surgery seems to predict the procedure's success rates2. LSG performed without calibration (tube) could result in inconsistent staple lines, with retained high sleeve volume and consequent failure. Traditionally, although different tubes are used for gastric decompression and calibration, this protocol interrupts operation room (0R) workflow. Accidental stapling of orogastric tubes and bougies do occur in the OR but are seldom reported. The need for this multiple tube system can be obviated with the ViSiGi™ Calibration Tube System. A single, multipurpose tube that integrates all these various steps could prevent breaks in OR; improve workflow; reduce patient injuries, cross contamination and transmission of infections; and a consistent and reproducible staple line. A similar device has been in use in Europe, Australia and Asia, but the ViSiGi™ Calibration Tube System is the first of its kind to be approved by the FDA. Currently, there are no data on its clinical safety/efficacy in comparison to standard care of separate orogastric tube and bougie in the United States. Therefore, 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.
- 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 Time, Ensure Consistent and Reproducible Staple Lines.
- Being tested
- Utilization of ViSiGi calibration tube, Usual non suction Bougie
- Keywords
- ViSiGi, Calibration tube, Sleeve gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilization of ViSiGi calibration tubeDevice
Also called ViSiGi 3D
Utilization of ViSiGi calibration tube
Usual non suction BougieDevice
Usual non suction Bougie
| Study group | Role | What they receive |
|---|---|---|
| ViSiGi | Experimental | Utilization of ViSiGi calibration tube Receives: Device: Utilization of ViSiGi calibration tube |
| Usual standard of care | Active comparator | Usual non suction Bougie Receives: Device: Usual non suction Bougie |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed;Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital and Health Network, Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Leonardo Claros, St. Luke's Hospital and Health Network, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008825
- Sponsor's protocol ID
- SLHN2013-62
- Acronym
- ViSiGi
- Status last verified
- Dec 2013
- First submitted
- 7 Nov 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26318Weiner 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.
PubMed 18098398Abu-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.
PubMed 21963196Pequignot 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.
PubMed 21769286Sanchez 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.
PubMed 16608608Vennes JA. Infectious complications of gastrointestinal endoscopy. Dig Dis Sci. 1981 Jul;26(7 Suppl):60S-64S. doi: 10.1007/BF01300809.
PubMed 6765053Kovaleva 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.
PubMed 23554415Schembre DB. Infectious complications associated with gastrointestinal endoscopy. Gastrointest Endosc Clin N Am. 2000 Apr;10(2):215-32.
PubMed 10683209
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the ViSiGiTM Calibration System for Effectiveness With Sleeve Visual Delineation at Various Suction Levels.
- ClinicalTrials.gov ID
- NCT02008825
- Acronym / sponsor ID
- ViSiGi / SLHN2013-62
- 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 Time, Ensure Consistent and Reproducible Staple Lines.
- Keywords
- ViSiGi, Calibration tube, Sleeve gastrectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- St. Luke's Hospital and Health Network, PennsylvaniaUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that using the ViSiGi™ Calibration Tube System in patients undergoing LSG will:
- 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 time; and
- ensure consistent and reproducible staple lines.
Detailed description
Laparoscopic Sleeve Gastrectomy (LSG), is now widely used as a stand-alone procedure for long-term weight loss. With fewer potential morbidities, comparable weight loss and greater ease of conversion to other procedures, many patients now opt for LSG as their bariatric procedure of choice. During surgery gastric decompression and calibration are compulsory for patient safety, gastric anatomic delineation, ease of surgery and optimal weight loss. The removed gastric volume at surgery seems to predict the procedure's success rates2. LSG performed without calibration (tube) could result in inconsistent staple lines, with retained high sleeve volume and consequent failure. Traditionally, although different tubes are used for gastric decompression and calibration, this protocol interrupts operation room (0R) workflow. Accidental stapling of orogastric tubes and bougies do occur in the OR but are seldom reported. The need for this multiple tube system can be obviated with the ViSiGi™ Calibration Tube System. A single, multipurpose tube that integrates all these various steps could prevent breaks in OR; improve workflow; reduce patient injuries, cross contamination and transmission of infections; and a consistent and reproducible staple line. A similar device has been in use in Europe, Australia and Asia, but the ViSiGi™ Calibration Tube System is the first of its kind to be approved by the FDA. Currently, there are no data on its clinical safety/efficacy in comparison to standard care of separate orogastric tube and bougie in the United States. Therefore, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViSiGi | Experimental | Device: Utilization of ViSiGi calibration tubeUtilization of ViSiGi calibration tube |
| Usual standard of care | Active comparator | Device: Usual non suction BougieUsual non suction Bougie |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Utilization of ViSiGi calibration tubeAlso: ViSiGi 3DUtilization of ViSiGi calibration tube | Device | ViSiGi |
| Usual non suction BougieUsual non suction Bougie | Device | Usual standard of care |
Primary outcome
Efficasy
Time frame: 3 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Background: PubMed 26318Satiani 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.
- Background: PubMed 18098398Weiner 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.
- Background: PubMed 21963196Abu-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.
- Background: PubMed 21769286Pequignot 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.
- Background: PubMed 16608608Sanchez 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.
- Background: PubMed 6765053Vennes JA. Infectious complications of gastrointestinal endoscopy. Dig Dis Sci. 1981 Jul;26(7 Suppl):60S-64S. doi: 10.1007/BF01300809.
- Background: PubMed 23554415Kovaleva 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.
- Background: PubMed 10683209Schembre DB. Infectious complications associated with gastrointestinal endoscopy. Gastrointest Endosc Clin N Am. 2000 Apr;10(2):215-32.
- ViSiGi web siteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Utilization of ViSiGi calibration tube and Usual non suction Bougie in people with Enhance Delineation of the Stomach Anatomy and the Surgeon's Appreciation of the Extent of Gastric Volume to be Removed; and Increase the Safety Profile of the Patient (i.e., Reduce the Likelihood of Accidental Stapling of the Orogastric Tube or Bougie);, run by St. Luke's Hospital and Health Network, Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo Claros, MD (4844262600, Leonardo.Claros@sluhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficasy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02008825, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.