- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03776188
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Arkansas
-
Little Rock, Arkansas, 미국, 72211
- University of Arkansas
-
-
Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic Jacksonville
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Jacksonville, Florida, 미국, 32256
- Borland Grover Clinic
-
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Illinois
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Evanston, Illinois, 미국, 60201
- NorthShore University HealthSystem
-
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Maryland
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Baltimore, Maryland, 미국, 21224
- Johns Hopkins Medical Institution
-
-
Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University
-
-
New York
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Manhasset, New York, 미국, 11030
- Northwell Health
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New York, New York, 미국, 10021
- New York Presbyterian Hospital
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New York, New York, 미국, 10029
- Mount Sinai Hospital
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033
- Penn State Hershey Medical Center
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Texas
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Dallas, Texas, 미국, 75214
- Methodist Dallas Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
no groups - observational study
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Dislocation of Stent - distance
기간: Change at 2 weeks, 30 days, 3 months
|
Change in the position measured using distance (centimeters).
|
Change at 2 weeks, 30 days, 3 months
|
Dislocation of Stent - location
기간: Change at 2 weeks, 30 days, 3 months
|
Change in the position measured using location.
Location options: Bridging the GJ anastomosis, Confined to gastric lumen, Bridging the pylorus, Bridging Lower Esophageal Sphincter
|
Change at 2 weeks, 30 days, 3 months
|
Migration Rate of Stent - placement
기간: Change at 2 weeks, 30 days, 3 months
|
Distal from placement over time (yes or no)
|
Change at 2 weeks, 30 days, 3 months
|
Migration Rate of Stent - replaced
기간: Change at 2 weeks, 30 days, 3 months
|
Stent replaced or re-structured over time (yes or no)
|
Change at 2 weeks, 30 days, 3 months
|
Migration Rate of Stent - sutures
기간: Change at 2 weeks, 30 days, 3 months
|
Number of intact Sutures
|
Change at 2 weeks, 30 days, 3 months
|
Migration Rate of Stent - removal
기간: Change at 2 weeks, 30 days, 3 months
|
Days to removal and replacement
|
Change at 2 weeks, 30 days, 3 months
|
Excess Weight Loss
기간: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
|
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.
|
Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
|
Total Weight Loss
기간: Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
|
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.
|
Measured at 2 weeks, 30 days, 3 months, 6 months, 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jennifer Maranki, MD, Penn State Milton S. Hershey School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ES Registry 2-682-101
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
수술에 대한 임상 시험
-
Assistance Publique Hopitaux De Marseille완전한심혈관 질환 | 비만 환자 | Bariatric Surgery 전후의 이러한 TRL의 생성률프랑스
-
Dong Yang알려지지 않은복강경 보조 수술 | 절개 없는 복강경 전수술(Natural Orifice Transluminal Endoscopic Surgery, NOSES)중국
-
University Hospital, Strasbourg, France모병Cervico-Facial Surgery ENT 프랑스의 학술 의료 및 외과 교육 | Cervico-Facial Surgery ENT Medical 레지던트(Auvergne-Rhône-Alpes, Grand Est, Ile de France, Nouvelle Aquitaine 및 Provence-Alpes-Côte d'Azur 지역)프랑스