成人の小腸の OCT ガイド付き経鼻イメージング
The investigators are seeking healthy adult participants 18-60 years and healthy pregnant women in their 2nd trimester of pregnancy for a research study to assess a new imaging device. The Tearney Laboratory at the Wellman Center for Photomedicine at Massachusetts General Hospital is developing high-resolution imaging devices that can be used to improve diagnostics in gastrointestinal diseases.
調査の概要
詳細な説明
The investigators have developed a device that can image the duodenum (the first part of the small intestine). The device consists of a thin, flexible tube with a small internal camera inside of it that takes high-resolution images of the gastrointestinal tract. The device will be introduced through the nose and then advanced into the stomach and duodenum. Participant tolerability, imaging quality and the optimal imaging technique will be evaluated. The results of this study will be used as the basis for a larger study to be conducted at the Aga Khan University Hospital in Pakistan where subjects with suspected or diagnosed EED will be imaged.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
-
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:
- Healthy participants
- Participants who are in their 2nd trimester of pregnancy
- Participant must be 18-60 years of age
- Participant must be able to consent to the procedure.
- Participant must fast (no solid food) for at least 8 hours and have no liquids within 2 hours prior to the procedure.
Exclusion Criteria:
- Participants with a history of upper respiratory disease or surgery
- Pregnant women with high-risk pregnancies such as history of: hyperemesis gravidarum, HIV, severe anemia or any other high-risk pregnancy conditions at the discretion of the subject's physician and the PI
- Participants with a history of upper gastrointestinal surgery
- Pregnant women with Type 1 diabetes
- Pregnant women with Type 2 diabetes on medication and gestational diabetes requiring medication
- Pregnant women with gestational thrombocytopenia
- Participants with upper respiratory infection at least 7 days prior to the procedure
- Pariticipants with any contraindications to the placement of the NJ tube including deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc.
- Participants on medications that delay gastric emptying.
- Participants on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
- Participants using nasal steroids or any steroids for environmental allergies.
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：デバイスの実現可能性
- 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 |
|---|---|
|
実験的：Feasibility of TNIB catheter
The feasibility of using the TNIB catheter to obtain microscopic images of the intestine. Healthy adult participants, and healthy pregnant women in their 2nd trimester of pregnancy will be enrolled, and their upper gastrointestinal tract will be imaged by the TNIB device |
Pariticipants will be asked to fast for 8 hours prior to study procedure and no liquids 2 hours prior to study procedure. Lidocaine jelly will may be used to help insert the TNIB Catheter through the Nares. Once inserted past the pharynx, imaging will begin. We will attempt to image the duodenum within 3 hours of study procedure starting. |
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 |
|---|---|---|
|
Ability for participant to tolerate the device
時間枠：3 hours
|
Can the participant tolerate the administration of the device with minimal discomfort? |
3 hours
|
|
Ability to visualize gastrointestinal features
時間枠：6 months
|
Can the technology successfully visualize gastrointestinal features? |
6 months
|
協力者と研究者
捜査官
- 主任研究者：Guillermo Tearney, M.D, PhD.、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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。