Trial Outcomes & Findings for Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy (NCT NCT03939819)
NCT ID: NCT03939819
Last Updated: 2024-05-21
Results Overview
Staple usage will be recorded during the weight loss surgery procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
During sleeve gastrectomy (up to 5 hours)
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
ViSiGi® 3D Suction Calibration Device
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.
ViSiGi® 3D suction calibration 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.
|
Esophagogastroduodenoscopy (EGD) Calibration
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
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|---|---|---|
|
Overall Study
STARTED
|
50
|
56
|
|
Overall Study
COMPLETED
|
48
|
56
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
ViSiGi® 3D Suction Calibration Device
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.
ViSiGi® 3D suction calibration 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.
|
Esophagogastroduodenoscopy (EGD) Calibration
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
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|---|---|---|
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Overall Study
Death
|
2
|
0
|
Baseline Characteristics
Number analyzed in row differs from overall because there was one pre-op weight missing in each group.
Baseline characteristics by cohort
| Measure |
ViSiGi® 3D Suction Calibration Device
n=50 Participants
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.
ViSiGi® 3D suction calibration 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.
|
Esophagogastroduodenoscopy (EGD) Calibration
n=56 Participants
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.80 years
STANDARD_DEVIATION 11.14 • n=50 Participants
|
43.90 years
STANDARD_DEVIATION 12.13 • n=56 Participants
|
43.38 years
STANDARD_DEVIATION 11.63 • n=106 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=50 Participants
|
47 Participants
n=56 Participants
|
89 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=50 Participants
|
9 Participants
n=56 Participants
|
17 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=50 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=50 Participants
|
47 Participants
n=56 Participants
|
87 Participants
n=106 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=50 Participants
|
9 Participants
n=56 Participants
|
18 Participants
n=106 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=50 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=50 Participants
|
39 Participants
n=56 Participants
|
73 Participants
n=106 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=50 Participants
|
15 Participants
n=56 Participants
|
28 Participants
n=106 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=50 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=106 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=50 Participants
|
2 Participants
n=56 Participants
|
5 Participants
n=106 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
56 participants
n=56 Participants
|
106 participants
n=106 Participants
|
|
Mean total body weight at 1-2 months prior to surgery
|
138.1 Kg
STANDARD_DEVIATION 28.7 • n=49 Participants • Number analyzed in row differs from overall because there was one pre-op weight missing in each group.
|
135.7 Kg
STANDARD_DEVIATION 27.8 • n=55 Participants • Number analyzed in row differs from overall because there was one pre-op weight missing in each group.
|
137.0 Kg
STANDARD_DEVIATION 29.4 • n=104 Participants • Number analyzed in row differs from overall because there was one pre-op weight missing in each group.
|
PRIMARY outcome
Timeframe: During sleeve gastrectomy (up to 5 hours)Staple usage will be recorded during the weight loss surgery procedure.
Outcome measures
| Measure |
ViSiGi® 3D Suction Calibration Device
n=50 Participants
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.
ViSiGi® 3D suction calibration 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.
|
Esophagogastroduodenoscopy (EGD) Calibration
n=56 Participants
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
|
|---|---|---|
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Number of Staple Load Firings
|
5.26 Number of staples
Standard Deviation 0.78
|
5.42 Number of staples
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: During sleeve gastrectomy (up to 5 hours)Surgery start and completion time will be recorded, and operative duration will be calculated
Outcome measures
| Measure |
ViSiGi® 3D Suction Calibration Device
n=50 Participants
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.
ViSiGi® 3D suction calibration 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.
|
Esophagogastroduodenoscopy (EGD) Calibration
n=56 Participants
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
|
|---|---|---|
|
Operative Duration (Time)
|
93.38 minutes
Standard Deviation 28.10
|
94.42 minutes
Standard Deviation 36.50
|
SECONDARY outcome
Timeframe: During sleeve gastrectomy (up to 5 hours)Population: Data for this study outcome was not collected due to internal limitations of the study.
Cost data (administrative data) will be retrieved from internal database
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)Population: Number of participants analyzed only included patients that were able to complete the questionnaire at each time point, which is different for each follow up.
GERD-HRQL questionnaire will be administered pre-operatively and post-operatively. The instrument contains a total of 10 scaled items which are scored, and a patient-reported global satisfaction assessment which is not added to the total GERD-HRQL score. Higher score correlates with worse outcome. Scale: No symptoms = 0; Symptoms noticeable, but not bothersome = 1; Symptoms noticeable and bothersome, but not every day = 2; Symptoms bothersome every day = 3; Symptoms affect daily activities = 4; Symptoms are incapacitating, unable to do daily activities = 5
Outcome measures
| Measure |
ViSiGi® 3D Suction Calibration Device
n=50 Participants
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.
ViSiGi® 3D suction calibration 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.
|
Esophagogastroduodenoscopy (EGD) Calibration
n=56 Participants
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
|
|---|---|---|
|
GERD Symptom Severity Score
GERD-HRQL Score at 1-2 months prior to surgery
|
4.54 score on a scale
Standard Deviation 5.7
|
3.82 score on a scale
Standard Deviation 5.67
|
|
GERD Symptom Severity Score
GERD-HRQL Score at 12 months post-operatively (+/- 12 - 24 months)
|
2.58 score on a scale
Standard Deviation 4.15
|
2.64 score on a scale
Standard Deviation 3.79
|
|
GERD Symptom Severity Score
GERD-HRQL Score at 3 weeks post-operatively (+/- 2 weeks)
|
3.00 score on a scale
Standard Deviation 4.33
|
5.66 score on a scale
Standard Deviation 9.56
|
SECONDARY outcome
Timeframe: 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)Population: Unable to get reliable weight loss data for the early post-op time frame for 3 weeks post-operatively (+/- 2 weeks). Number of participants analyzed for the long-term follow up included patients that completed the appointment including weight check.
Total body weight was calculated in Kg.
Outcome measures
| Measure |
ViSiGi® 3D Suction Calibration Device
n=31 Participants
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.
ViSiGi® 3D suction calibration 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.
|
Esophagogastroduodenoscopy (EGD) Calibration
n=38 Participants
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
|
|---|---|---|
|
Body Weight
Body weight at 12 months post-operatively (+/- 12 - 24 months)
|
108.2 Kg
Standard Deviation 24.9
|
106.7 Kg
Standard Deviation 24.5
|
Adverse Events
ViSiGi® 3D Suction Calibration Device
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Esophagogastroduodenoscopy (EGD) Calibration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ViSiGi® 3D Suction Calibration Device
n=50 participants at risk
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.
ViSiGi® 3D suction calibration 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.
|
Esophagogastroduodenoscopy (EGD) Calibration
n=56 participants at risk
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration: Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.0%
1/50 • Number of events 1 • From date of surgery up to 12 months post-operatively (+/- 12 - 24 months).
The PI will be informed of serious adverse events (AEs) as soon as they occur by Co-Investigators (i.e.,surgeons performing sleeve gastrectomy) and/or the study coordinator and notify the Medical board (MB) within 48 hours of becoming aware of the event. The PI will report serious AEs and unanticipated problems (UPs) to his or her IRB within 5 business days of becoming aware of the event. Data collection for Adverse events is still ongoing.
|
0.00%
0/56 • From date of surgery up to 12 months post-operatively (+/- 12 - 24 months).
The PI will be informed of serious adverse events (AEs) as soon as they occur by Co-Investigators (i.e.,surgeons performing sleeve gastrectomy) and/or the study coordinator and notify the Medical board (MB) within 48 hours of becoming aware of the event. The PI will report serious AEs and unanticipated problems (UPs) to his or her IRB within 5 business days of becoming aware of the event. Data collection for Adverse events is still ongoing.
|
|
Nervous system disorders
Cerebral Accident
|
2.0%
1/50 • Number of events 1 • From date of surgery up to 12 months post-operatively (+/- 12 - 24 months).
The PI will be informed of serious adverse events (AEs) as soon as they occur by Co-Investigators (i.e.,surgeons performing sleeve gastrectomy) and/or the study coordinator and notify the Medical board (MB) within 48 hours of becoming aware of the event. The PI will report serious AEs and unanticipated problems (UPs) to his or her IRB within 5 business days of becoming aware of the event. Data collection for Adverse events is still ongoing.
|
0.00%
0/56 • From date of surgery up to 12 months post-operatively (+/- 12 - 24 months).
The PI will be informed of serious adverse events (AEs) as soon as they occur by Co-Investigators (i.e.,surgeons performing sleeve gastrectomy) and/or the study coordinator and notify the Medical board (MB) within 48 hours of becoming aware of the event. The PI will report serious AEs and unanticipated problems (UPs) to his or her IRB within 5 business days of becoming aware of the event. Data collection for Adverse events is still ongoing.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place