Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (EUPHORIA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Derivation Cohort: derive optimum diagnostic MSOT thresholds
研究概览
简要总结
The clinical investigation aims to generate clinical data to support the use of Multispectral Optoacoustic Tomography (MSOT) in clinical practice, its inclusion in diagnostic guidelines and to support its reimbursement, specifically to
- Further validate the application with respect to including ulcerative colitis patients
- Prepare a study protocol for large-scale clinical validation study in inflammatory bowel disease (IBD)
- Successfully execute the clinical validation study
详细描述
The clinical investigation, EUPHORIA, will pave the way to establish Multispectral Optoacoustic Tomography (MSOT) technology for the non-invasive assessment of intestinal inflammation in patients. EUPHORIA will enable commercialization of the technology by finalizing technical improvements that will increase diagnostic outcome beyond what has been shown in a first feasibility study, will improve usability, prepare CE marking for the new device and validate clinical results in a large clinical investigation.
Inflammatory bowel disease (IBD) is a chronic condition, posing significant burden to patients and health care systems. Patients suffer from a relapsing course of intestinal inflammation, and to date, there is no satisfying noninvasive diagnostic modality for monitoring disease activity. In a recent clinical study conducted by University Hospital Erlangen, MSOT, a technology developed by iThera Medical (ITM), has proven to be superior in diagnostic performance to other procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of UC or CD for at least three months prior to enrollment
- •Age ≥ 18 years
- •Indication for endoscopy according to institutes routine care
- •Written informed consent
排除标准
- •Stoma independent of localization, ileoanal pouch
- •Prior bowel surgery other than ileocecal resection, which potentially affects the study procedure by fundamentally changing bowel anatomy by removing the ROI (e.g. (partial) resection of the sigmoid, left sided colon) or repositioning the ROI to an inaccessible location (e.g. right-sided colectomy with transversostomy)
- •Indeterminate Colitis, irritable bowel syndrome (IBS)
- •Involvement of the upper gastrointestinal (GI) track only
- •Isolated proctitis
- •Complications, such as infectious enteritis, infectious colitis and infectious enterocolitis, abscess formation, intestinal obstruction, toxic megacolon
- •Tattoo in skin area of interest
- •Skin lesions, scar tissue or skin diseases affecting the area of imaging
- •Highly pigmented skin in the area of imaging (e.g. Fitzpatrick skin type V and VI)
- •The bowel wall is invisible in the Ultrasound image of the MSOT system
- •Medication leading to increased light sensitivity
- •Pregnant and breastfeeding women
- •Mental retardation of the patient with restriction of general judgment and awareness
- •Exclusion due to safety concerns of investigator (subject who has any condition, including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study)
结局指标
主要结局
Derivation Cohort: derive optimum diagnostic MSOT thresholds
时间窗: 5-10 days
Derivation cohort: The primary endpoint of the derivation cohort is to derive optimum diagnostic MSOT thresholds based on receiver operating characteristics (ROC) analysis to distinguish endoscopic active disease from remission in Crohn's Disease (CD) or Ulcerative Colitis (UC) patients.
Validation cohort: re-assess the diagnostic accuracy of MSOT
时间窗: 5-10 days
Validation cohort: The primary endpoint of the validation cohort is to re-assess the diagnostic accuracy of MSOT to distinguish endoscopic active disease from remission in an independent cohort. It will be considered successful if a lower 90% confidence of limit at least 75% of area under curve (AUC) is reached
次要结局
- Derivation Cohort: MSOT thresholds(9-10 months)
- Derivation Cohort: MSOT performance, diagnostic accuracy measures(9-10 months)
- Derivation Cohort: MSOT performance, diagnostic accuracy(9-10 months)
- Both cohorts: patient preference(5-10 days)
- Validation Cohort: MSOT performance, diagnostic accuracy measures(through study completion, an average of 1 year)
- Validation Cohort: MSOT performance, diagnostic accuracy(through study completion, an average of 1 year)
- Both cohorts: performance of other non-invasive diagnostic modalities(through study completion, an average of 1 year)
- Both cohorts: diagnostic accuracy(through study completion, an average of 1 year)
- Both cohorts: likelihood ratios and predictive values for active inflammation(through study completion, an average of 1 year)
- Both cohorts: performance of MSOT in combination with other modalities(through study completion, an average of 1 year)
- Both cohorts: discriminate different grades of disease activity(through study completion, an average of 1 year)
- Both cohorts: interobserver variability(through study completion, an average of 1 year)
- Derivation cohort: MSOT thresholds using clinical scores as a reference(through study completion, an average of 1 year)