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

Abdominal Adhesions Clinical Trial

— NOTES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962650
• Other study ID #: CI-08-0007
• Status: Completed
• Phase: N/A
• First received: August 12, 2009
• Last updated: March 1, 2012
• Start date: June 2009
• Est. completion date: October 2010

Study information

• Verified date: March 2012
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Adhesions

Intervention

Device:
• Transgastric diagnostic peritoneoscopy with laparoscopic assistance
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)

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No