Natural Orifice Transgastric Endoscopic (NOTES) Transgastric Diagnostic Peritoneoscopy With Laparoscopic Assistance

Study Overview
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Brief Summary
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The study will document being able to successfully perform transgastric diagnostic peritoneoscopy (laparoscopic visualization) using a small collection of study surgical tools.

Official Title
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A Feasibility Trial to Evaluate Natural Orifice Transgastric Endoscopic Diagnostic Peritoneoscopy With Laparoscopic Assistance.

Conditions
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Abdominal Adhesions

Intervention / Treatment
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* Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women will be enrolled in this study who: Are willing to give consent and comply with evaluation and treatment schedule; At least 18 years of age; Are a candidate for surgical weight loss intervention (i.e. meet ASMBS and NIH criteria) for an RYGB procedure at the Investigational site; Have a history of open abdominal surgery or laparoscopic abdominal surgery; ASA Classification I, II, or III (Appendix II); and Have a negative serum pregnancy test (for women of childbearing potential). Exclusion Criteria: Subjects will be excluded from the study for any of the following: Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable); Acute cholecystitis or acute pancreatitis; Evidence of abdominal abscess or mass; Diffuse peritonitis; Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy; Clinical diagnosis of sepsis; Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial; Planned concurrent surgical procedure other than RYGB or adhesiolysis; Prior or planned major surgical procedure within 30 days before or after study procedure; Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints; Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or Any condition which precludes compliance with the study (Investigator discretion).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOTES Toolbox<br>Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial | Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance<br>* Device: Natural Orifice Transgastric Endoscopic (NOTES GEN 1 Toolbox): Articulating Hook Knife(IN2505), Articulating Snare (IN2503), Articulating Needle Knife(IN2504), Articulating Graspers(IN2501 or IN2506), Articulating Biopsy Forceps(IN2502), Steerable Flexible Trocar (IN0501) with Rotary Access Needle (IN0502), Flexible Bipolar Hemostasis Forceps (IN0301), and/or Flexible Maryland Dissector(IN1601)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Diagnostic Peritineoscopy | Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome. | Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal adhesions, diagnostic peritoneoscopy, Natural Orifice Transluminal Endoscopic Surgery, NOTES