Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery
調査の概要
詳細な説明
Endolumik Inc. has developed a fluorescence-guided calibration device, the Endolumik Gastric Calibration Tube, to improve visualization during bariatric operations. The present pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs. During this clinical study, the single-use, disposable Endolumik Gastric Calibration Tube will be used during twenty sleeve gastrectomy operations and gastric bypass operations. The goal of the present study is to confirm that the Endolumik Gastric Calibration Tube performs similar to predicate devices currently on the market, as well as to get end-user feedback prior to submitting a 510(k) application to the U.S. Food and Drug Administration (FDA).
In this multicenter trial, both study sites are certified as Bariatric Centers of Excellence through the American Society of Metabolic and Bariatric Surgery. The first clinical site is Ruby Memorial Hospital, part of West Virginia University; the second clinical site is Durham Regional Hospital, part of Duke University.
To date, using funding from a West Virginia Clinical & Translational Science Institute Launch Pilot Grant, our team has validated the device and associated methods of fluorescence-guided sleeve gastrectomy and fluorescence-guided gastric bypass in ex-vivo and in-vivo porcine models, as well as human cadaveric tissue models. Based on FDA criteria, this investigational device meets the definition of a Non-Significant Risk (NSR) device; the risk classification document is included with submission materials.
The investigational device provided will have met design controls per FDA code of federal regulation (CFR): 21 CFR 820.30. Endolumik Inc. will serve as the industry sponsor for this study and will donate the devices being used for the protocol to the two participating study sites. Development of the technology in this research is supported by the West Virginia University Department of Surgery.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mara McFadden
- 電話番号：5104684426
- メール：mcfadden@endolumik.com
研究連絡先のバックアップ
- 名前：Nova Szoka, Dr.
- 電話番号：13049067613
- メール：szoka@endolumik.com
研究場所
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West Virginia
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Morgantown、West Virginia、アメリカ、26505
- West Virginia University
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コンタクト：
- Katie Schneller
- 電話番号：304-293-3993
- メール：wvusponsoredprograms@mail.wvu.edu
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コンタクト：
- Lawrence Tabone, Dr.
- 電話番号：3042931728
- メール：letabone@hsc.wvu.edu
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主任研究者：
- Lawrence Tabone, Dr.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- English speaking
- Adults (between age of 18 and 65 years old)
- Have body mass index (BMI) between 35 and 65.99 kg/m2
- Male or female bariatric patients undergoing bariatric surgery at one of the two sites included in the protocol.
Exclusion Criteria:
- Nonbariatric patients
- Patients who have conditions that preclude a sleeve gastrectomy or gastric bypass operation
- Patients with esophageal stricture
- Patients with esophageal varices
- Patients with a Zenker's diverticulum
- Patients aged 66 and older
- Patients with a BMI of 66 kg/m2 or greater
- Pregnant Women
- Lactating Women
- Other vulnerable patient populations: pregnant and lactating women, prisoners, cognitively impaired and critically ill subjects.
研究計画
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：処理
- 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 |
|---|---|
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実験的：Bariatric Surgery
Up to twenty participants meeting inclusion criteria will undergo laparoscopic or robotic sleeve gastrectomy using the Endolumik Gastric Calibration Tube instead of the standard bougie calibration tube.
Up to ten participants meeting inclusion criteria will undergo laparoscopic gastric bypass using the Endolumik Gastric Calibration Tube instead of the standard calibration tube.
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Up to twenty participants will undergo laparoscopic or robotic sleeve gastrectomy using the EGCT. This operation will take approximately 60 minutes. The portions of the sleeve gastrectomy operation where the EGCT will be used include:
The portions of the gastric bypass operation where the EGCT will be used include:
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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 |
|---|---|---|
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Intraoperative adverse events
時間枠：During surgical treatment
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Adverse events occurring during surgical treatment
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During surgical treatment
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Operative time
時間枠：During surgical treatment
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Duration of surgical treatment
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During surgical treatment
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30-day morbidity
時間枠：30 days post surgical treatment
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any 30-day Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Occurrences
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30 days post surgical treatment
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis. 2018 Mar;14(3):259-263. doi: 10.1016/j.soard.2017.12.013. Epub 2017 Dec 16.
- Mahawar KK. Bougie-Related Oesophageal Injury with Bariatric Surgery: An Unrecognised Problem. Obes Surg. 2016 Aug;26(8):1935-6. doi: 10.1007/s11695-016-2213-1. No abstract available.
- Lovece A, Rouvelas I, Hayami M, Lindblad M, Tsekrekos A. Cervical esophageal perforation caused by the use of bougie during laparoscopic sleeve gastrectomy: a case report and review of the literature. BMC Surg. 2020 Jan 10;20(1):9. doi: 10.1186/s12893-020-0679-1.
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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