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

2026년 6월 9일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

5

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 오스트리아
    • State of Vienna
      • Vienna, State of Vienna, 오스트리아, 1090
        • Medical University of Vienna

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 장치 타당성
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: IGBalloon treatment
20 patients
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Complication rate (Clavien Dindo grade 3b) of the IGBalloon
기간: up to 52 weeks
Rate of re-operation in %
up to 52 weeks
Weight loss of the IGBalloon
기간: up to 52 weeks
Total weight loss in %
up to 52 weeks
Remission of comorbidities of the IGBalloon
기간: up to 52 weeks
Remission of comorbidities (art. Hyperention, DMII, obstructive sleep apnea) in %
up to 52 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Medical University of Vienna

수사관

  • 연구 책임자: Gerhard Prager, Univ. Prof., Medical University of Vienna

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 3월 1일

기본 완료 (실제)

2024년 7월 15일

연구 완료 (실제)

2024년 7월 15일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1921/2022

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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