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NCT05086302 · ClinicalTrials.gov registry record

Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

A clinical trial of Obesity, sponsored by Spatz FGIA.

Completed
Registry status
537
Enrollment target
20
Study locations

NCT05086302: Completed study of Obesity, sponsored by Spatz FGIA.

NCT05086302 is a study of Obesity that has completed, run by Spatz FGIA. The registered enrollment target is 537 participants, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05086302, a study of Obesity, has completed, sponsored by Spatz FGIA.

COMPLETED
Registry status
537 participants
Enrollment target
20
Study locations

Study Summary

A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The study aims to demonstrate that the safety of the device in the post market setting is comparable to what was observed in the US pivotal study.

Conditions Studied

Obesity

Study Locations (20)

New Jersey

  • Reveal Weight Loss - Livingston
  • Weight Loss and Wellness Center - Livingston
  • New Jersey Bariatric Center - Springfield
  • New York Bariatric Group - Wayne Location - Wayne

Florida

  • JSAPA - Jupiter
  • Formation - Tampa

Maryland

  • Gastro Center of Maryland - Columbia
  • The Silhouette Clinic - Germantown

North Carolina

  • True You Weight Loss - Cary
  • Atlantic Medical Group - Kinston

Virginia

  • Endoscopic Wellness Center of America - Reston
  • Advanced Gastroenterology & Hepatology of Greater Washington - Vienna

California

  • Carson D Liu MD Medical Corp - Marina del Rey

Georgia

  • True You Weight Loss (Atlanta) - Atlanta

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 537 participants
Start Date 2021-12-03
Est. Completion 2025-01-13

Sponsor

Spatz FGIA

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05086302

The ClinicalTrials.gov registry entry for NCT05086302 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 537 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (34% lower). The listed sponsor is Spatz FGIA, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 0 interventions.

NCT05086302 reports 20 study locations spanning 13 distinct geographic areas - top geographies include New Jersey, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT05086302 about?

NCT05086302 is a clinical study titled "Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study". A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program....

What is the current status of trial NCT05086302?

This trial is currently completed. The enrollment target is 537 participants. The study started on 2021-12-03. Estimated completion is 2025-01-13.

What conditions does trial NCT05086302 study?

This clinical trial studies the following conditions: Obesity.

Who is sponsoring clinical trial NCT05086302?

This trial is sponsored by Spatz FGIA, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05086302 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.