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ObesityNCT04306445

How Gas-Filled Intragastric Balloons or Endoscopic Sleeve Gastroplasty Affect Hunger, Hunger Hormones, and Gastric Emptying Compared to Meal Replacements

A study testing GF-IGB: Obalon Balloon, Medically Supervised Meal Replacement Program: My New Weigh and Endoscopic sleeve gastroplasty: (ESG) in people with Obesity, run by University of Colorado, Denver at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The disease obesity continues to be a major health issue in the US with over one third of the population having a mass index >30 kg/m2. Obesity is associated with serious cardiometabolic complications including diabetes, hypertension, dyslipidemia and myocardial infarction. Read more about this study

Who is it for?
Ages 22 to 65 years
Conditions the study is for
Obesity
What is being tested?
GF-IGB: Obalon Balloon, Medically Supervised Meal Replacement Program: My New Weigh and Endoscopic sleeve gastroplasty: (ESG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
2 Mar 2020to 22 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female participants aged 22-65
  • Weight Stable (<5% weight change in the last 3 months)
  • Initiating treatment with GF-IGB, ESG, or medically supervised MRP
  • BMI of 30-40

Who cannot join

  • History of liver disease
  • History of uncontrolled thyroid disease
  • History of anemia
  • History of diabetes
  • History of eating disorder
  • History of uncontrolled depression defined as a score of ≥ 10 on PHQ-9 (Patient Health Questionnaire-9)
Show all 14Show fewer
  • Use of weight loss medications in the past 3 months
  • History of gastroparesis
  • History of bariatric surgery
  • History to allergy or intolerance to any component of the meal used in the gastric emptying study or mixed meal test
  • Women who are pregnant or lactating
  • Currently incarcerated
  • Non English speaking
  • Decisionally challenged adults

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: The Effect of a Gas-filled Intragastric Balloon or Endoscopic Sleeve Gastroplasty for Weight Loss Compared With a Meal Replacement Weight Loss Program on Gastric Emptying, Hormonal Adaptation to Weight Loss, and Hunger

The disease obesity continues to be a major health issue in the US with over one third of the population having a mass index >30 kg/m2. Obesity is associated with serious cardiometabolic complications including diabetes, hypertension, dyslipidemia and myocardial infarction. Rates of successful obesity treatment with weight loss and weight maintenance remain low. Several endoscopic bariatric therapies and procedures have been approved for use in the United States, including three intragastric balloon systems (2 fluid-filled and one gas-filled) and endoscopic sleeve gastroplasty (ESG), both of which have lower risks than bariatric surgery and do not alter gastrointestinal anatomy. Weight loss with all intragastric balloons and ESG is higher than lifestyle therapy or weight loss medications, but less than bariatric surgery. Unlike weight loss medications where weight loss from the medication is regained within 6-8 months after therapy ends, weight loss maintenance with intragastric balloons remains high with 66-88.5% of the weight loss maintained 6 months after device removal. Data suggests that space occupying devices with a volume of 400 ml or more in the stomach increase feelings of fullness and result in weight loss, but this does not explain the prolonged effect of weight loss maintenance after balloon removal. Although few studies have investigated the mechanism of action of fluid-filled balloons and one study with 4 patients undergoing ESG on weight loss, these data suggest that gastric emptying as well as space occupation contribute to weight loss. However, no studies have investigated the mechanisms of action of gas filled intragastric balloons on weight loss.

Understanding the mechanisms responsible for weight loss with the gas filled intragastric balloon system and ESG as well as any weight loss independent effects on blood glucose control would lay the groundwork for studies evaluating predictors of response to improve patient selection as well as studies understanding the mechanisms behind weight loss maintenance and developing strategies to prolong weight loss maintenance.

Therefore, the purpose of this pilot study is to determine the effects 10% total body weight loss (%TBWL) in patients with obesity treated with the intragastric balloon (GF- IGB) system or ESG compared to patients with obesity treated with a meal replacement program (MRP) on 1) gastric emptying, 2) hormonal adaptation to weight loss and 3) hunger.

Read the detailed description

Obesity is a chronic disease, which is associated with and contributes to multiple medical co- morbidities including but not limited to cardiovascular disease, diabetes, nonalcoholic fatty liver disease, and many different cancers. Obesity is also associated with an increased risk of all-cause mortality. Despite these known risks, treatment remains limited. This has contributed to the increase in the prevalence of obesity with 42.4%% of adults in the US adults having a body mass index (BMI) >30 kg/m2.

Endoscopic bariatric therapies are a new class of treatment for obesity, which have demonstrated more weight loss than lifestyle therapy alone and fewer complications than bariatric surgery with less weight loss than bariatric surgery. Four endoscopic devices are currently approved by the FDA for the treatment of obesity, including two intragastric balloons (IGB). One of the balloons systems are fluid filled (FF-IGB) and one is gas filled (GF-IGB). Although the GF-IGB system is swallowed, all the balloon systems require an endoscopist for endoscopic removal. In clinical registry series, these balloons demonstrate similar weight loss at 6 months. Unlike weight loss medications, weight loss maintenance is prolonged after IGB removal, which was demonstrated meta-analysis of studies and case series outside of the US of the single FF-IGB demonstrated weight loss maintenance after balloon removal 9 and in the US pivotal trials. While the occupancy of space in the stomach by IGB is known to induce satiation and satiety, this mechanism is only present with the IGB in place. Therefore, the prolonged effects of weight loss maintenance after IGB removal suggest other mechanisms contributing to weight loss with IGB treatment beyond space occupation. ESG is completed endoscopically with a device that has FDA 510k clearance for tissue apposition in the GI tract. Weight loss with ESG in a recent meta-analysis in 1772 patients demonstrated 16.5% TBWL at 12 months and 17.2% TBWL at 18-245 months. Understanding the mechanisms contributing to weight loss with the GF-IGB system and ESG will lay the groundwork for future studies to enhance the effect of IGBs and ESG on initial weight loss, patient selection, and weight loss maintenance; increasing benefits to patients treated with IGBs or ESG.

FF-IGB are known to delay gastric emptying. This is consistent with practice patterns as patients reliably have food left in their stomachs after an overnight fast requiring multiple days of liquid diet prior to endoscopic removal to avoid aspiration. In one study, the FF-IGB delayed gastric emptying compared to both baseline and a control group and the change in gastric emptying was associated with weight loss. Gastric emptying has been studied in only 4 patients before and after ESG. In these 4 patients, there was a 90-minute increase to the time for 50% of emptying of solid foods, however the limited number of patients in that study reduce overall certainty of the effect of ESG on gastric emptying. No studies have investigated the effects of the GF-IGB on gastric emptying. This protocol will clarify the effects of the GF-IGB and ESG on gastric emptying compared with a control group matched on weight loss. This will elucidate the weight loss independent effects of the devices since patients will be studied at baseline and 10% total body weight loss.

Another possible mechanism by which IGBs and ESG may induce weight loss and weight loss maintenance is through alterations in gut hormones. Ghrelin is a hormone secreted by X/A like cells, which are predominantly in the fundus of the stomach. Ghrelin concentrations fluctuate with eating, increasing pre-meals and decreasing in response to food in the stomach. Moreover, infusion of ghrelin stimulates eating in humans and is the only known hormone secreted from the GI tract to stimulate hunger. Weight loss with lifestyle therapy alone has been shown to increase fasting and meal test "active" or acyl-ghrelin concentrations, which correlated with increased hunger on visual analogue scale (VAS) testing. Acyl-Ghrelin concentrations were still elevated at one year after weight loss despite weight regain of almost 50%, which suggests that acyl-ghrelin plays and important role in weight regain. Studies investigating ghrelin concentrations in the setting of FF-IGBs have been mixed, demonstrating decreased fasting plasma total ghrelin concentrations, no change in fasting or meal test ghrelin concentrations in FF-IGB or control groups, increased fasting plasma ghrelin compared to a control group at months 1 and 6 with decreased ghrelin in the active arm compared to the control arm after removal and increased ghrelin concentrations in a single arm. However, these studies measured total ghrelin not acyl ghrelin. This limits the reliability of the data especially since no change in ghrelin concentrations were seen in control patients with weight loss in which an increase in acyl- ghrelin is expected. Moreover, all the studies were with FF-IGB and none were in the GF-IGB system.

Balloon type may have an effect on acyl-ghrelin concentrations, as GF-IGB tend to float in the fundus and body of the stomach, which may affect the IGB's ability to suppress acyl-ghrelin secretion. In one of the aforementioned studies a post-hoc analysis demonstrated that the small number of patients whose FF-IGBs localized to the fundus had greater suppression of ghrelin.

Fasting ghrelin has been evaluated in one study with 12 patients pre and post ESG. Fasting ghrelin concentrations did not increase with weight loss, but meal testing was not performed.

Therefore, this protocol will determine the effects of 10% TBWL from either GF-IGB system treatment or ESG treatment compared to lifestyle and meal replacement therapy on acyl-ghrelin concentrations, the active form of ghrelin, which stimulates hunger, and the sensation of hunger with the VAS. This will allow for the detection of effects that are specific to either procedure and independent of weight loss.

Conditions
Obesity
Being tested
GF-IGB: Obalon Balloon, Medically Supervised Meal Replacement Program: My New Weigh, Endoscopic sleeve gastroplasty: (ESG)
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GF-IGB: Obalon BalloonDevice

    The balloon, which is attached to a thin catheter, is swallowed by the patient in a standing position. Once the two-step verification of balloon passage into the stomach by both fluoroscopy and pressure reading, the balloon is inflated to a volume of 250 ml with a nitrogen-mix gas, additional imaging of the inflated balloon is obtained, the catheter is ejected from the balloon, and the catheter is pulled out through the patient's mouth. The process is repeated at week 2 for the second balloon and between weeks 4-8 for the third balloon. All patients are given an individualized calorie prescription by a registered dietitian for a goal of up to 2 pounds of weight loss per week. The balloons are removed endoscopically 6 months after placement of the first balloon. Patients also attend monthly virtual individual diet coaching and monthly virtual group behavior coaching sessions both delivered by a registered dietitian for twelve months focused on long-term behavior change.

  • Medically Supervised Meal Replacement Program: My New WeighDietary supplement

    Patients are given an individualized calorie prescription by a registered dietitian for a goal of 2 pounds weight loss per week. Patients are seen in a group-based program once a week focused on long-term behavior change and use meal replacements for a nutritionally balanced very low-calorie diet for 20 weeks. 4-5 meal replacements are consumed per day. If only 4 meal replacements are consumed, individuals eat 3 servings of vegetables and 2 servings of fruit per day as well.

  • Endoscopic sleeve gastroplasty: (ESG)Procedure or surgery

    Endoscopic sleeve gastroplasty is a weight loss procedure that uses an FDA 510K cleared endoscopic suturing device known as Overstitch to reduce the size of the gastric body. The procedure is completed with an endoscope. It is inserted through the mouth, down the esophagus, and into the stomach. Sutures with 8-10 bites 1.5-2 cm apart in a U-shape pattern are placed starting distally 6 cm proximal to the pylorus. Additional sutures are placed moving proximally up to 2 cm distal to the gastroesophageal junction. An additional row of sutures is then placed again in the distal to proximal stomach to complete the gastroplasty. All patients are given an individualized calorie prescription by a registered dietitian for a goal of up to 2 pounds of weight loss per week. Patients also attend monthly virtual individual diet coaching and monthly virtual group behavior coaching sessions both delivered by a registered dietitian for twelve months focused on long-term behavior change.

Study groups in NCT04306445
Study groupRoleWhat they receive
GF-IGB: Obalon BalloonActive comparatorObalon balloons are gas-filled balloons used for weight loss by taking up more space in the stomach. There are three separate balloons that are placed. They are inflated once the capsules containing the balloons are swallowed. The second balloon is swallowed two weeks after the first balloon, and the third balloon is swallowed four to eight weeks after the second balloon. All three balloons are removed six months after the first balloon is placed.
Receives: Device: GF-IGB: Obalon Balloon
Medically Supervised Meal Replacement Program: My New WeighActive comparatorMeal Replacements are used for weight loss in order to achieve a very low-calorie diet that is nutritionally balanced. Four to five meal replacements are consumed per day. If only four meal replacements are consumed per day, three servings of vegetables and two servings of fruit are consumed as well. This program lasts for about five months or twenty weeks.
Receives: Dietary Supplement: Medically Supervised Meal Replacement Program: My New Weigh
Endoscopic Sleeve Gastroplasty: ESGActive comparatorEndoscopic sleeve gastroplasty (ESG) is a weight loss procedure that uses an endoscopic suturing device known as Overstitch to reduce the size of the stomach. This decreases the amount of food one can consume, which leads to the consumption of fewer calories throughout the day, resulting in weight loss.
Receives: Procedure: Endoscopic sleeve gastroplasty: (ESG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Loss

    10%TBWL by GI-IGB, ESG, or Medically Supervised MRP

    Measured: 6 months

Secondary outcomes (5)

  1. Gastric emptying measured by technetium 99 gastric emptying study

    The investigators hypothesize that treatment with GF-IGB and ESG will result in greater gastric retention of contents at 2 hours compared with patients who are treated with MRP.

    Measured: 6 months

  2. Acyl-Ghrelin measured at multiple times points during a mixed meal test (MMT)

    The investigators hypothesize that weight loss induced increase in active ghrelin concentrations seen during a mixed meal tolerance test will be lower in patients treated with GF- IGB and ESG compared with patients treated with MRP.

    Measured: 6 months

  3. Glucose measured at multiple times points during a mixed meal test (MMT)

    There will be no difference in glucose concentrations in patients treated with GF-IGB and ESG compared with treatments treated with MRP.

    Measured: 6 months

  4. Insulin measured at multiple times points during a mixed meal test (MMT)

    There will be no difference in insulin concentrations in patients treated with GF-IGB and ESG compared with treatments treated with MRP.

    Measured: 6 months

  5. Level of hunger measured using a visual analog scale (Hunger VAS)

    The investigators hypothesize that hunger will increase before and during a MMT after weight loss with MRP but will not change from baseline after weight loss with GF-IGB and ESG treatment. Scales will range from 0-100, with 100 being more hungry (worse outcome) and 0 being less hungry (better outcome).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start2 Mar 2020
  3. Primary completion22 Feb 2024
  4. Study completion22 Feb 2024

Why it stopped: The Principal Investigator left the University of Colorado

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04306445
Sponsor's protocol ID
19-0278
Status last verified
May 2026
First submitted
6 Mar 2020
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Courcoulas A, Abu Dayyeh BK, Eaton L, Robinson J, Woodman G, Fusco M, Shayani V, Billy H, Pambianco D, Gostout C. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes (Lond). 2017 Mar;41(3):427-433. doi: 10.1038/ijo.2016.229. Epub 2016 Dec 23.

    PubMed 28017964

  • Ponce J, Woodman G, Swain J, Wilson E, English W, Ikramuddin S, Bour E, Edmundowicz S, Snyder B, Soto F, Sullivan S, Holcomb R, Lehmann J; REDUCE Pivotal Trial Investigators. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015 Jul-Aug;11(4):874-81. doi: 10.1016/j.soard.2014.12.006. Epub 2014 Dec 16.

    PubMed 25868829

  • Thompson CC, Abu Dayyeh BK, Kushner R, Sullivan S, Schorr AB, Amaro A, Apovian CM, Fullum T, Zarrinpar A, Jensen MD, Stein AC, Edmundowicz S, Kahaleh M, Ryou M, Bohning JM, Ginsberg G, Huang C, Tran DD, Glaser JP, Martin JA, Jaffe DL, Farraye FA, Ho SB, Kumar N, Harakal D, Young M, Thomas CE, Shukla AP, Ryan MB, Haas M, Goldsmith H, McCrea J, Aronne LJ. Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial. Am J Gastroenterol. 2017 Mar;112(3):447-457. doi: 10.1038/ajg.2016.500. Epub 2016 Dec 6.

    PubMed 27922026

  • Sullivan S, Swain J, Woodman G, Edmundowicz S, Hassanein T, Shayani V, Fang JC, Noar M, Eid G, English WJ, Tariq N, Larsen M, Jonnalagadda SS, Riff DS, Ponce J, Early D, Volckmann E, Ibele AR, Spann MD, Krishnan K, Bucobo JC, Pryor A. Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss. Surg Obes Relat Dis. 2018 Dec;14(12):1876-1889. doi: 10.1016/j.soard.2018.09.486. Epub 2018 Sep 29.

    PubMed 30545596

  • Agnihotri A, Xie A, Bartalos C, Kushnir V, Sullivan S, Islam S, Islam E, Lamet M, Lamet A, Farboudmanesch R, Overholt BF, Altawil J, Early DS, Bennett M, Lowe A, Mullady DK, Adeyeri CS, El Zein M, Mishra P, Fayad L, Dunlap M, Oberbach A, Cheskin LJ, Kalloo AN, Khashab MA, Kumbhari V. Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1081-1088.e1. doi: 10.1016/j.cgh.2018.02.026. Epub 2018 Mar 2.

    PubMed 29481969

  • Vargas EJ, Pesta CM, Bali A, Ibegbu E, Bazerbachi F, Moore RL, Kumbhari V, Sharaiha RZ, Curry TW, DosSantos G, Schmitz R, Agnihotri A, Novikov AA, Pitt T, Dunlap MK, Herr A, Aronne L, Ledonne E, Kadouh HC, Cheskin LJ, Mundi MS, Acosta A, Gostout CJ, Abu Dayyeh BK. Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1073-1080.e1. doi: 10.1016/j.cgh.2018.01.046. Epub 2018 Feb 7.

    PubMed 29425781

  • Geliebter A, Westreich S, Gage D. Gastric distention by balloon and test-meal intake in obese and lean subjects. Am J Clin Nutr. 1988 Sep;48(3):592-4. doi: 10.1093/ajcn/48.3.592.

    PubMed 3414573

  • Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.

    PubMed 27465076

  • Mion F, Napoleon B, Roman S, Malvoisin E, Trepo F, Pujol B, Lefort C, Bory RM. Effects of intragastric balloon on gastric emptying and plasma ghrelin levels in non-morbid obese patients. Obes Surg. 2005 Apr;15(4):510-6. doi: 10.1381/0960892053723411.

    PubMed 15946431

  • Ariyasu H, Takaya K, Tagami T, Ogawa Y, Hosoda K, Akamizu T, Suda M, Koh T, Natsui K, Toyooka S, Shirakami G, Usui T, Shimatsu A, Doi K, Hosoda H, Kojima M, Kangawa K, Nakao K. Stomach is a major source of circulating ghrelin, and feeding state determines plasma ghrelin-like immunoreactivity levels in humans. J Clin Endocrinol Metab. 2001 Oct;86(10):4753-8. doi: 10.1210/jcem.86.10.7885.

    PubMed 11600536

  • Wren AM, Seal LJ, Cohen MA, Brynes AE, Frost GS, Murphy KG, Dhillo WS, Ghatei MA, Bloom SR. Ghrelin enhances appetite and increases food intake in humans. J Clin Endocrinol Metab. 2001 Dec;86(12):5992. doi: 10.1210/jcem.86.12.8111.

    PubMed 11739476

  • Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.

    PubMed 22029981

  • Martinez-Brocca MA, Belda O, Parejo J, Jimenez L, del Valle A, Pereira JL, Garcia-Pesquera F, Astorga R, Leal-Cerro A, Garcia-Luna PP. Intragastric balloon-induced satiety is not mediated by modification in fasting or postprandial plasma ghrelin levels in morbid obesity. Obes Surg. 2007 May;17(5):649-57. doi: 10.1007/s11695-007-9109-z.

    PubMed 17658025

  • Mathus-Vliegen EM, Eichenberger RI. Fasting and meal-suppressed ghrelin levels before and after intragastric balloons and balloon-induced weight loss. Obes Surg. 2014 Jan;24(1):85-94. doi: 10.1007/s11695-013-1053-5.

    PubMed 23918282

  • Konopko-Zubrzycka M, Baniukiewicz A, Wroblewski E, Kowalska I, Zarzycki W, Gorska M, Dabrowski A. The effect of intragastric balloon on plasma ghrelin, leptin, and adiponectin levels in patients with morbid obesity. J Clin Endocrinol Metab. 2009 May;94(5):1644-9. doi: 10.1210/jc.2008-1083. Epub 2009 Mar 3.

    PubMed 19258408

Questions about this trial

What is this clinical trial studying?

A study testing GF-IGB: Obalon Balloon, Medically Supervised Meal Replacement Program: My New Weigh and Endoscopic sleeve gastroplasty: (ESG) in people with Obesity, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The Principal Investigator left the University of Colorado). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Loss (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04306445, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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