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

NCT00962650 | Completed Results

• 1 other identifier: CI-08-0007
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Adhesions

Keywords

abdominal adhesions; diagnostic peritoneoscopy; Natural Orifice Transluminal Endoscopic Surgery; NOTES

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

NOTES Toolbox

EXPERIMENTAL

Multiple devices designed for trans-orifice use during surgical procedures; used for transvaginal cholecystectomy in this trial

Device: Transgastric diagnostic peritoneoscopy with laparoscopic assistance

Interventions

Transgastric diagnostic peritoneoscopy with laparoscopic assistance DEVICE

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)

NOTES Toolbox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Limitations and Caveats

Ten male and female subjects indicated for Diagnostic Peritoneoscopy in advance of Roux-en Y Gastic Bypass procedure, who had a history of previous abdominal surgery, and met study Inclusion Criteria, were enrolled in the study.

Results Point of Contact

• Title: Michael Schwiers, Principal Biostatistician
• Organization: Ethicon Endo-Surgery, Inc.

mschwier@its.jnj.com

513-337-1172

Study Officials

• Jeffrey W Hazey, MD, FACS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 20, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 29, 2012
• Results First Posted: March 29, 2012

Record last verified: 2012-03

Locations

US (1)