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The IGBallon (R) - for Use in the Treatment of Obesity (IGBallon)

2026年6月9日 更新者：Gerhard Prager、Medical University of Vienna

Intra-gastric Balloon (IGBalloon(R)) for Use in the Treatment of Obesity - a Pilot Study

This study is a prospective, non-randomized, open-label, single-center study.

The aim of this study is to assess the safety of the IGballoon in the human body. The effectiveness of the IGBalloon in relation to weight loss behaviour of the human body will also be investigated. This study will involve 20 participants who will be divided into two groups:

  1. Monitoring group with 5 participants who swallow an IGBalloon. After four weeks, safety will be tested. Up to four additional IGBalloons may be ingested, if necessary, over the following eight weeks.
  2. Treatment group of 15 participants receiving up to 5 IGBalloons over a period of 8 weeks as required. This group will be evaluated for efficiency of the IGBalloon.

Various examinations, such as clinical examinations, blood tests, and gastroscopies will be carried out at certain follow-up points. Patients also receive dietary support for the entire duration of the study.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The study will be divided into a screening phase and treatment period. Informed consent must be obtained prior to conducting any screening or other study-related procedures or evaluations.

The screening phase will take place 28 days prior to the administration/ingestion of the first device. Participants will be evaluated against the protocol-specific inclusion and exclusion criteria to determine their eligibility for participation in the study. An initial five (5) participants meeting eligibility requirements will ingest a single IGBalloon, undergo an immediate endoscopy to assess device inflation and initial condition of the gastric mucosa and will be followed-up at 1, 2, 4, 6, and 8 weeks.

At the 2 week follow-up appointment, a second IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety.

At the 4 week follow-up appointment, again, an additional IGBalloon may be ingested if there is no decrease in weight and/or increase in satiety.

At the 6 week follow-up appointment, an additional IGBalloon may be ingested if there is still no decrease in weight and/or increase in satiety.

At the 8 week follow-up, an additional device (maximum of 5) for the same reasons mentioned above.

The initial 5 sentinel patients will undergo an endoscopy to observe balloon inflation and condition of the gastric mucosa. No more than five (5) IGBalloons may be ingested by a single participant. In the event that no significant changes have occurred to the gastric mucosa and no other unanticipated serious adverse events have occurred in the initial five participants, a further 15 participants will begin the treatment and follow-up regimen. This larger cohort of participants will not undergo the endoscopy procedure at the 8 week follow-up but follow the same treatment and follow-up regimen in all other aspects.

Further follow-up consultations will occur at 12, 16, 20, 24 and 36 weeks following the ingestion of the first IGBalloon. A final 52-week follow-up will include an additional endoscopy procedure on all participants. Following the 52 week follow-up of all participants, the study will be deemed to have been completed. Participants may elect to keep the IGBalloons in place, or have them removed at the 52 week endoscopy procedure. Those participants electing to keep the balloons in place will be monitored on an ongoing basis. Should participants require follow-up for adverse events or require any additional clinical laboratory or physical examinations, they may return to the clinic as deemed appropriate by the physician.

研究の種類

介入

入学 (実際)

5

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • オーストリア
    • State of Vienna
      • Vienna、State of Vienna、オーストリア、1090
        • Medical University of Vienna

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Body Mass Index (BMI) greater than 35 or greater than 30 with comorbidities (type 2 diabetes, dyslipidemia, hypertension, obstructive sleep apnea, osteoarthritis, or coronary heart disease).
  • Male or female participants aged between 18-70 years and representative of the general population.
  • Availability for the entire study period, and willingness to adhere to protocol requirements as evidenced by giving signed informed consent.
  • Failure at previous attempts at weight loss through diet, exercise, and/or behavior modification.

Exclusion Criteria:

  • Severely obese (BMI > 45) or >120 kg.
  • Previous gastric surgery affecting the esophagus, stomach, or pylorus that would interfere with ingestion or placement of the IGBalloon.
  • Debilitating comorbidities preventing surgery.
  • Inflammatory disease of the gastrointestinal (GI) tract.
  • Upper-GI bleeding conditions.
  • History of gastrointestinal ulcers or bleeding.
  • Existing gallbladder disease.
  • Positive breath test for the presence of H. pylori infection.
  • Gastro-esophageal reflux resistant to proton pump inhibitors.
  • Previously diagnosed with Cushing's disease and/or hypothyroidism.
  • Malignant disease.
  • Likely to require abdominal surgery during the study period.
  • Upper-GI abnormalities or anatomical variants likely to interfere with the study procedure.
  • Symptomatic documented hiatal hernia.
  • Insulin-dependent diabetes mellitus.
  • Life expectancy of less than 2 years.
  • Participation in another clinical trial investigating a therapeutic device or medicine.
  • Major prior or present psychological or psychiatric disorder (including a history of drug and/or alcohol addiction, severe depression, Electroconvulsive Therapy (ECT) treatment - current or recent.)
  • Inability to tolerate blood draws.
  • Inability or unwillingness to swallow large items after coaching in swallowing technique.
  • If female, lactating or positive pregnancy test at screening or before each of the treatment periods.
  • If female and of child-bearing potential, unwillingness to abstain from sexual intercourse or use a medically acceptable method of contraception from 14 days before the study and throughout the entire study period.

Acceptable methods of contraception:

  1. Hormonal contraceptive, if used for at least 3 months prior to study.
  2. Intrauterine device (IUD).
  3. Condom and spermicide.
  4. Diaphragm and spermicide.
  5. Abstinence.

  6. Surgical sterilization of either partner.

    • Previously defined non-compliance with prescribed medical care.
    • Identified eating disorder likely to significantly increase risk of complication.
    • Prior enrolment in this study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：デバイスの実現可能性
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：IGBalloon treatment
20 patients
デバイス：IGBalloon
An initial five participants meeting eligibility requirements will ingest one IGBalloon(IGB), undergo an immediate endoscopy to assess device inflation and condition of the gastric mucosa and will be followed-up at 1, 2, 4, 6 and 8 weeks. At the 2-week follow-up, a second IGB is ingested in the event that there is no decrease in weight or increase in satiety. After 4-weeks, an additional IGB is ingested in the event that there is no decrease in weight and increase in satiety. After 6-weeks, an additional IGB may be ingested in the event that there is no decrease in weight and increase in satiety. After 8-weeks, an additional device (max. of 5) may be ingested in the event that there is no decrease in weight and increase in satiety. The initial 5 sentinel patients will undergo a controlendoscopy. No more than five IGB are ingested. If no significant changes or unanticipated SAEs have occurred in the initial five participants, a further 15 participants will begin the treatment.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Complication rate (Clavien Dindo grade 3b) of the IGBalloon
時間枠：up to 52 weeks
Rate of re-operation in %
up to 52 weeks
Weight loss of the IGBalloon
時間枠：up to 52 weeks
Total weight loss in %
up to 52 weeks
Remission of comorbidities of the IGBalloon
時間枠：up to 52 weeks
Remission of comorbidities (art. Hyperention, DMII, obstructive sleep apnea) in %
up to 52 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Medical University of Vienna

捜査官

  • スタディディレクター：Gerhard Prager, Univ. Prof.、Medical University of Vienna

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年3月1日

一次修了 (実際)

2024年7月15日

研究の完了 (実際)

2024年7月15日

試験登録日

最初に提出

2026年5月20日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月15日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 1921/2022

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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