---
title: Obalon US Commercial Registry
nct_id: NCT03688256
overall_status: COMPLETED
sponsor: Surgical Specialists of Louisiana
study_type: OBSERVATIONAL
primary_condition: Obesity
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03688256.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03688256"
ct_last_update_post_date: 2018-09-28
last_seen_at: "2026-05-12T07:08:41.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Obalon US Commercial Registry

**Official Title:** Obalon Balloon System: Real-World Evidence Commercial Site Registry

**NCT ID:** [NCT03688256](https://clinicaltrials.gov/study/NCT03688256)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 1343
- **Lead Sponsor:** Surgical Specialists of Louisiana
- **Collaborators:** Obalon Therapeutics, Inc.
- **Conditions:** Obesity
- **Start Date:** 2017-01-01
- **Completion Date:** 2018-08-28
- **CT.gov Last Update:** 2018-09-28

## Brief Summary

Retrospective study of the data reported in the Obalon US Commercial Registry

## Detailed Description

Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Started Obalon Balloon Therapy between Jan.-Dec. 2017
* Weight loss data through balloon removal
* BMI \>25kg/m2
```

## Interventions

- **Obalon Balloon System** (DEVICE) — 6 month Obalon Intragastric Balloons

## Primary Outcomes

- **Primary Safety Outcome - Serious Adverse Events** _(time frame: 6 months)_ — Percentage of Patients with Serious Adverse Events
- **Primary Effectiveness Outcome - Weight Loss Metrics** _(time frame: 6 months)_ — Mean Weight Loss Metrics

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03688256.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03688256*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*