Coronary Artery Disease, Diabetes, Gastroesophageal Reflux Disease, Hyperlipidemia, Hypertension, Osteoarthritis, Sleep Apnea
Conditions
Keywords
gastric bypass, Gastric bypass surgery
Brief summary
The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
Interventions
DEVICETri Staple Technology stapler
This is a single arm study.
Sponsors
Medtronic - MITG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* The patient must be 18-65 years of age. * The patient has a BMI of 40-60 kg/m2, or 35-40 kg/m2 with one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass. * The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.
Exclusion criteria
* The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc) * The patient is pregnant. * The patient has an active or history of, infection at the operative site. * The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent. * Patient has an abdominal ventral hernia requiring mesh repair * The patient has a history of clinically significant liver disease * The patient has a history of drug or alcohol abuse within 2 years of enrollment * The patient has a history of venous thrombosis or pulmonary embolism * The patient has a history of coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients With an Uneventful Creation of a Functional Staple Line | Day 0 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Intra-operative Bleeding Requiring Intervention | Day 0 and 1 month |
| Length of Hospital Stay | Date of discharge which averages 3 days |
| Incidence of Serosal Tearing | 30 days post op |
Countries
United States
Participant flow
Pre-assignment details
thirty patients consented, 1 was excluded by physician for elevated liver function test; 1 was not considered enrolled as subject did not receive study device in error, leaving 28 enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| Tri Staple This is a single arm study.
Tri Staple Technology stapler : This is a single arm study. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | did not receive study device bc of error | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Tri Staple |
|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 28 |
| serious Total, serious adverse events | 2 / 28 |
Outcome results
Primary
Proportion of Patients With an Uneventful Creation of a Functional Staple Line
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tri Staple | Proportion of Patients With an Uneventful Creation of a Functional Staple Line | 28 participants |
Secondary
Incidence of Intra-operative Bleeding Requiring Intervention
Time frame: Day 0 and 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tri Staple | Incidence of Intra-operative Bleeding Requiring Intervention | 19 participants |
Secondary
Incidence of Serosal Tearing
Time frame: 30 days post op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tri Staple | Incidence of Serosal Tearing | 0 participants |
Secondary
Length of Hospital Stay
Time frame: Date of discharge which averages 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tri Staple | Length of Hospital Stay | 3.2 days | Standard Deviation 0.5 |