- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00854074
Neurostimulation for the Treatment of Post-Operative Ileus
연구 개요
상세 설명
The purpose of this study is to investigate the effects of neurostimulation in the epidural space in the spine on the activity of the enteric nervous system (ENS).
ElectroCore has successfully studied POI in an animal model and believes that temporary neurostimulation of the spine may be useful in re-starting the ENS in humans, resulting in the resumption of coherent GI motility in the gut and normal bowel function in a shorter period of time than currently occurs. Electrical pulses will be used to modulate the signals that may be preventing a return to normal GI activity. This device and procedure used in this study are similar to the system and procedure used to implant the temporary trial stimulator used evaluate the effectiveness of spine pain stimulation prior to implantation of the permanent device.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern
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Maryland
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Baltimore, Maryland, 미국, 21205
- Johns Hopkins Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19106
- Pennsylvania Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or Female, Age >18 years, < 65 years
- Partial small or large bowel open resection with primary anastomosis
- 120 hours post-operative with no signs of functional bowel activity
- Able to give Informed Consent
By Post-Op Day 5, patient care has involved at least 3 of the following conservative therapies to minimize long term POI:
i. post-operative, patient controlled opioid analgesia ii. removal of intra-operative nasogastric tube at time of surgery or on post-operative day 1 iii. advancement of liquid diet iv. advancement of solid food v. ambulation vi. use of chewing gum
Exclusion Criteria:
- Pregnant
- Undergoing surgery for repair of penetrating trauma injury, gangrene or ischemic bowel
- Evidence of anastomotic leak, abdominal infection, sepsis, bowel perforation, mechanical small bowel obstruction or metabolic derangement (e.g., low potassium/magnesium)
- Presence of existing implanted or external stimulator for pain or other indications (including pacemaker)
- Operative blood lost of > 500 cc
- Significant scarring of the skin along the lower thoracic/lumbar spine or deformation of thoracic spinal canal from congenital, developmental or traumatic causes, or previous extensive spinal thoracic surgery other than diskectomy
- Received a lumbar or thoracic epidural block placed immediately prior to surgery
- Body Mass Index > 35
- Unstable cardiac status
- Severe hypertension
- American Society of Anesthesiologists (ASA) Score greater than/equal to 3
- On anti-coagulation therapy (other than aspirin) or has an underlying bleeding disorder
- Active or suspected pelvic infection
- Unable to communicate perception of the stimulation
- Significant surgical complications where in the view of the physician, participation in the study could further complicate subject care (i.e. infection at surgical site, deep venous thrombosis, respiratory complications, etc)
- Treatment with Entereg (alvimopam) during post-operative period
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 2
Subject will be observed until recovery of normal GI function
|
|
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실험적: 1
Spinal neurostimulation
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An electrical neurostimulation signal will be applied to the spine
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
To validate the design of ElectroCore Resolution Motility System™ , to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours
기간: 30 days
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30 days
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
To confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional motility in subjects experiencing post-operative paralytic ileus.
기간: 48 hours
|
48 hours
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Michael Erdeck, MD, Johns Hopkins Medical Center
- 수석 연구원: David Walega, MD, Northwestern University Medical Center
- 수석 연구원: Robert Frye, MD, Pennsylvania Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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
- IL - 01
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