Morbid Obesity
Conditions
Keywords
Obesity, Weight Loss
Brief summary
The main objective of this trial is to evaluate endoscopic visualization during a laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally through a new device called a Steerable Flex Trocar (SFT).
Interventions
DEVICENOTES toolbox
Using SFT for endoscope access during Transvaginal Sleeve Gastrectomy procedure. Visualization will occur through endoscope
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Women will be enrolled in this study who: * Are willing to give consent and comply with evaluation and treatment schedule; * Are 21 to 60 years of age (inclusive), post menopausal, or otherwise no longer expect to bear children, e.g., previous tubal ligation; * Are a candidate for surgical weight loss intervention (meets ASMBS and NIH criteria); * Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations; * Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial; * Are American Society of Anesthesiologists (ASA) Class I, II, or III); and * Have a negative pregnancy test (for women of childbearing potential).
Exclusion criteria
Subjects will be excluded from the study for any of the following: * Previous pelvic surgery other than transverse C-sections and/or tubal ligation; * Enlarged uterus; * Evidence of pelvic malignancy on a screening ultrasound; * Documented history of drug and/or alcohol abuse within 2 years of the Screening Visit; * Previous malabsorptive or restrictive procedures performed for the treatment of obesity; * Unable or unwilling to attend follow-up visits and examinations; * Planned or predicted concurrent surgical procedure; * Any medical condition which precludes compliance with the study; * Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders; * Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study; * History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma; * Use of prescription or over the counter weight reduction medications or supplements, participation in weight-loss programs, or change in smoking habits within 8 weeks of the Screening Visit and for the duration of study participation; * Participation in another clinical trial within 8 weeks of the Screening Visit and for the duration of this trial (unless previously approved by the investigator and Sponsor); or * Any condition which precludes compliance with the study (investigator discretion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Procedures Completed With Successful Endoscopic Visualization. | Assessed intra-operatively | The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transvaginal Sleeve Gastrectomy Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization) | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Transvaginal Sleeve Gastrectomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age Continuous | 48.3 years STANDARD_DEVIATION 11.64 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
Primary
Proportion of Procedures Completed With Successful Endoscopic Visualization.
The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.
Time frame: Assessed intra-operatively
Population: All subjects on whom the surgery was attempted represent the primary analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transvaginal Sleeve Gastrectomy | Proportion of Procedures Completed With Successful Endoscopic Visualization. | 4 participants |