Robotic Bariatric Database (RBD) Collaborative | NCT05540314

Studies
Robotic Bariatric Database (RBD) Collaborative

NCT05540314

Sponsor

Methodist Health System

Status

Completed

Last Update Posted

Jun 10, 2026Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Weight Loss
Obesity

Interventions

robotic bariatric surgery

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

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2022Actual

Primary Completion Date

Aug 10, 2023Actual

Completion Date

Aug 11, 2023Actual

First Submitted Date

Sep 12, 2022

First Submission Date that Met QC Criteria

Sep 12, 2022

First Posted Date

Sep 14, 2022Actual

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

Jun 8, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss. In 1991, the National Institutes of Health Conference Statement on Gastrointestinal Surgery for Severe Obesity developed a consensus stating that bariatric surgery was the most effective treatment for obesity since it is associated with good long-term results in terms of weight loss, glycemic control and decreased mortality.

To collect and store clinical data related to the treatment outcomes of robotic bariatric surgery in order to develop an evidence base such that physicians can provide the best possible care to patients undergoing surgical weight loss interventions.

Detailed Description

With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects that have undergone robotic bariatric surgery		Subjects that have undergone robotic bariatric surgery between January 2018 and December 2019	Procedure: robotic bariatric surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
robotic bariatric surgery	Procedure	robotic bariatric surgery	Subjects that have undergone robotic bariatric surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Date of Birth	mm/dd/yyyy	January 2018- December2019
Principal Operative Procedure is an Initial Primary Metabolic or Bariatric Procedure	Yes or No	January 2018- December 2019
Patient has a history of metabolic or bariatric surgery	Yes or No	January 2018- December 2019

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years of age
Eligible for or have undergone robotic bariatric surgery per the treating physician
Undergone robotic bariatric surgery between January 2018 and December 2019

Exclusion Criteria:

Do not meet the Study Inclusion Criteria l

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

3. Undergone robotic bariatric surgery between January 2018 and December 2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sachin S . Kukreja, MD	Methodist Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Charlton Medical Center		Dallas	Texas	75237	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss
D009765	Obesity

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided