Endostapler Gastric Bypass Study | NCT04712526

Studies
Endostapler Gastric Bypass Study

NCT04712526

Sponsor

Lexington Medical Inc.

Status

Withdrawn

Last Update Posted

Oct 4, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Obesity

Interventions

AEON Endostapler

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

voluntarily withdrawn

Expanded Access Info

Start Date

Jan 18, 2021Actual

Primary Completion Date

Nov 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jan 13, 2021

First Submission Date that Met QC Criteria

Jan 13, 2021

First Posted Date

Jan 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2023

Last Update Posted Date

Oct 4, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.

Detailed Description

Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AEON Endostapler		Stapling performed with AEON Endostapler	Device: AEON Endostapler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AEON Endostapler	Device	Surgery with AEON Endostapler	AEON Endostapler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of reported device-related adverse events		Within 30-day post-operative period

Secondary Outcomes

Measure	Description	Time Frame
Endoscopic staple line bleeding	Incidence of intraoperative staple line bleeding from endoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Endoscope Images (1: No bleeding, 5: Profuse Bleeding)	Within surgery
Laparoscopic staple line bleeding

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
Informed consent for study obtained and signed from each subject

Exclusion Criteria:

Planned open surgical approach
Use of staple line reinforcement material (buttress)
Revision or other bariatric procedure
Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or PTT > 45sec, or PT> 15sec, or INR>1.5
Patients with active HIV or Hepatitis B
Patients under the age of 18 on the date of the surgery
Patients who are pregnant
Patients using tobacco products within the last 2 weeks prior to surgery date
Patients using cortisone or related products within the last 2 weeks prior to surgery date

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

25 subjects

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holyoke Medical Center		Holyoke	Massachusetts	01040	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided