Endoscopic Suturing (ES) Registry
Prospective Registry for Trans-Orifice Endoscopic Suturing Applications
To determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable.
To evaluate the efficacy, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.
調査の概要
状態
条件
詳細な説明
To determine patient outcomes (survival, morbidity including hospitalization, additional re-interventions with radiologic, endoscopic or surgical procedures) with endoscopic suturing at predetermined intervals from the last endoscopic suturing procedure or at failure of the endoscopic suturing with conversion to another intervention such as surgery and compared to historical controls when applicable.
To evaluate the efficacy and safety of endoscopic suturing therapy in preventative fixation of stents and bariatric revision.
To collect data on the common use endoscopic suturing therapy in other indications.
This prospective clinical study is a real-world registry and not a randomized controlled trial. Given the conditions commonly treated with endoscopic suturing and the potential lack of equivalent expertise in open, laparoscopic, and trans-oral surgical procedures at all centers, randomization of participants is not possible nor ethical. In addition, there are clinical scenarios where endoscopic therapy with surgical sutures, tissue sealants, and/or endoprosthetics may be appropriate and open and laparoscopic surgical approaches inappropriate from an ethical viewpoint. Given the multitude of currently available minimally invasive approaches to repair, it would be unethical to expose and randomize patients who are suitable for more minimally invasive approaches to a more invasive and inherently more morbid approach.
This outcomes study is external to the subject receiving the medical device treatment. Subjects will receive the medical device treatment regardless of study participation and the surgery is not part of this research. Subjects will be consented prior to their procedure, to obtain basic follow-up information. If the subject provides informed consent to participate in the registry, then site staff will follow the participant's clinical data for the period of the registry. Site staff may also contact the subject(s) during their standard clinic visit or via the telephone and obtain information on: overall health, specific events related to any subsequent surgical, endoscopic, or radiologic interventions, and hospitalizations.
The clinical data will be collected during usual procedure follow-ups. This will include recording patient demographics, medications, testing results, comorbidities, body mass index, and reason for clinical care visit. If during the follow-up period, the subject undergoes additional clinically indicated procedures or hospitalizations for procedure related indications then the site will submit this information to the registry.
All procedures and device use will be performed as clinically indicated and as directed by the treating physician. All information requested as part of this registry will be obtained from clinical data obtained as part of study.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Arkansas
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Little Rock、Arkansas、アメリカ、72211
- University of Arkansas
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Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic Jacksonville
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Jacksonville、Florida、アメリカ、32256
- Borland Grover Clinic
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Illinois
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Evanston、Illinois、アメリカ、60201
- NorthShore University HealthSystem
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Maryland
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Baltimore、Maryland、アメリカ、21224
- Johns Hopkins Medical Institution
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University
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New York
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Manhasset、New York、アメリカ、11030
- Northwell Health
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New York、New York、アメリカ、10021
- New York Presbyterian Hospital
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New York、New York、アメリカ、10029
- Mount Sinai Hospital
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- Penn State Hershey Medical Center
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Texas
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Dallas、Texas、アメリカ、75214
- Methodist Dallas Medical Center
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Selected to undergo trans-orifice suturing prior to study enrollment
- Age 18+ years
- Patient ASA classification I, II, III, including emergency cases
- Patient willing to provide informed consent, cooperate with post-operative recommendations and follow-up assessment
Exclusion Criteria:
- Patients who do not meet the clinical criteria for trans-orifice suturing
- Under age 18 years
- ASA classification IV
- Unable to provide informed consent
- Unable to participate in follow-up assessments
- Uncorrectable coagulopathy at the time of endoscopic suturing
- Any terminal disease that limits patient's survival to less than one year
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
コホートと介入
グループ/コホート |
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no groups - observational study
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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 |
---|---|---|
Dislocation of Stent - distance
時間枠:Change at 2 weeks, 30 days, 3 months
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Change in the position measured using distance (centimeters).
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Change at 2 weeks, 30 days, 3 months
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Dislocation of Stent - location
時間枠:Change at 2 weeks, 30 days, 3 months
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Change in the position measured using location.
Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter
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Change at 2 weeks, 30 days, 3 months
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Migration Rate of Stent - placement
時間枠:Change at 2 weeks, 30 days, 3 months
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Distal from placement over time (yes or no)
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Change at 2 weeks, 30 days, 3 months
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Migration Rate of Stent - replaced
時間枠:Change at 2 weeks, 30 days, 3 months
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Stent replaced or re-structured over time (yes or no)
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Change at 2 weeks, 30 days, 3 months
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Migration Rate of Stent - sutures
時間枠:Change at 2 weeks, 30 days, 3 months
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Number of intact Sutures
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Change at 2 weeks, 30 days, 3 months
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Migration Rate of Stent - removal
時間枠:Change at 2 weeks, 30 days, 3 months
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Days to removal and replacement
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Change at 2 weeks, 30 days, 3 months
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Excess Weight Loss
時間枠:Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
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Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % excess weight lost and absolute terms.
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Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
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Total Weight Loss
時間枠:Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
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Changes in body weight measured in kilograms subsequent to the revisional procedure will be summarized using statistics both in percentage terms using the % total weight loss and absolute terms.
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Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
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協力者と研究者
捜査官
- 主任研究者:Jennifer Maranki, MD、Penn State Milton S. Hershey School of Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- ES Registry 2-682-101
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。
手術の臨床試験
-
Dong Yangわからない腹腔鏡補助下手術 | 切開を行わない全腹腔鏡手術(Natural Orifice Transluminal Endoscopic Surgery、NOSES)中国