Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorWeill Medical College of Cornell University
About this trial
The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 1 years after a subject consents for study participation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any patient who is considering undergoing EBT for weight loss within 6 months, or has undergone clinically indicated EBT for weight loss within the past 6 months
Above or equal to 18 years of age.
Disqualifiers
Any patient who has not undergone or will undergo EBT for weight loss
Below 18 years of age.
Trial population
Individuals who will undergo Endoscopic bariatric therapies.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Endoscopic Bariatric Therapies
Other interventionParticipation in this study will allow for data collection through medical chart review for at least 6 standard of care visits up to 1 year after consenting to participate in this registry study. The exposure of interest is total body weight loss, safety and efficacy
Treatment groups
9,999 Participants
are divided into 1 treatment groupGroup A: Endoscopic Bariatric Therapies (EBT).1 intervention
Trial outcomes
Primary outcomes
1
Change of weight of the various bariatric therapies
Compare mean percentage total body weight loss achieved via various Endoscopic Bariatric Therapies compared to baseline, 1 month, 6 months and 1 . year post procedure. This will be calculated by measuring the patients weight on a scale and comparing it to their baseline weight pre procedure.
Time frame
Baseline, 1 month, 6 months, and 1 year post procedure2
Safety of procedure measured by in the number of adverse events of procedure
Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline
Time frame
at baseline3
Safety of procedure measured by in the number of adverse events that occur within 30 days
Number of adverse events; Type (unexpected, expected, related, possibly related)
Time frame
Within 30 days of the procedureSecondary outcomes
1
Technical success of each bariatric therapy.
Technical success is the technical success of the procedure.
Time frame
through study completion at one year.2
Change and Improvement in comorbidities
measuring certain anthropometric measurements at baseline and at 6 months and one year. Waist Circumference in cm
Time frame
6 months, 1 year post procedure3
Change and Improvement in comorbidities
measuring certain anthropometric measurements at baseline and at 6 months and one year. Blood pressure mmHg
Time frame
6 months, 1 year post procedure4
Change and Improvement in comorbidities
measuring certain anthropometric measurements at baseline and at 6 months and one year. These include laboratory measurements (tryglicerides, LDL, A1C, Insulin)
Time frame
6 months, 1 year post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov