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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002193-84 | EudraCT Number |
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| Name | Class |
|---|---|
| Q Clinical Research AB | INDUSTRY |
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A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis.
The main purpose of the trial is to evaluate if Lumentin® 44 used as a bowel filling agent in MRE examination generates images with acceptable diagnostic quality.
In addition, the plasma electrolytes concentration levels, including, potassium, sodium, phosphate, and calcium, as well as ionized calcium will be evaluated over a 24 hour time period after intake of Lumentin.
This is an uncontrolled, single centre phase II trial. Enrolled HVs (n=10) will undergo Gd-enhanced MRE after oral intake of Lumentin® 44.
Interested HVs will be identified primarily among medical students at the medical hospitals at Malmö and Lund. Posters will be placed at the departments and invitation letters will be handed out.
The HVs interested in participating will be invited to attend a pre-screening visit where their suitability based on age and health status will be assessed. Fifteen HVs who fulfil the pre-screening criteria and are interested in participating will be asked to attend a screening visit at the clinic and if eligible for the trial they will then visit the clinic for the MRE assessment within 1-2 weeks.
Only the initial 10 of the eligible HVs will be asked to come for the MRE examination and the remaining eligible subjects will be asked to stand by in case any of the 10 subjects are unable to come or cannot undergo the examination.
HVs will be asked to fast for 6 hours prior to the examination on the day of the MRE examination. Small amount of clear liquid is allowed up to 2 decilitres. Prior to MRE, Lumentin® 44 will be provided to them in volumes of up to 1,500 mL and at least 1,100 mL of Lumentin® 44 must be drunk. The subjects will be asked to drink the solutions of oral contrast agent within 45 minutes to 1 hour.
Subjects not able to drink at least 1.1 L of Lumentin® 44 will be withdrawn from the trial.
Prior to the intake of Lumentin® 44, an IV antecubital cannula will be placed and used for blood sampling and administration of gadolinium (Gd) contrast agent during the MRE assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumentin® 44 | Experimental | Lumentin® 44 Powder for oral foam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumentin® 44 Powder for oral foam | Drug | Lumentin® 44 is a foam for oral use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Evaluation of MRE Images - Motility | Motility: MRE examinations with Lumentin® 44 will be scored with respect to motility status based on a 5-graded scale, as follows:
| Day 1 |
| Visual Evaluation of MRE Images -Artefacts | Artefacts: MRE examinations with Lumentin® 44 will be scored with respect to artefacts based on a 5-graded scale, as follows:
| Day 1 |
| Visual Evaluation of MRE Images -Mucosal Evaluation | Mucosal evaluation: MRE examinations with Lumentin® 44 will be scored with respect to mucosal status based on a 5-graded scale, as follows:
| Day 1 |
| Visual Evaluation of MRE Images -Overall Diagnostic Impression |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Plasma Sodium | Concentration of plasma sodium levels over time | Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) |
| Concentration of Plasma Potassium |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Leander | PeritusClinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PeritusClinic | Lund | Skåne County | 223 63 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumentin® 44 | Lumentin® 44 Powder for oral foam Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumentin® 44 | Lumentin® 44 Powder for oral foam Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Evaluation of MRE Images - Motility | Motility: MRE examinations with Lumentin® 44 will be scored with respect to motility status based on a 5-graded scale, as follows:
| All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed | Posted | Count of Participants | Participants | Day 1 |
|
From start of intake of study medication and 2 days after treatment. Trial subjects were in the trial between 23 JAN 2023 and 17 FEB 2023
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumentin® 44 | Lumentin® 44 Powder for oral foam Lumentin® 44 Powder for oral foam: Lumentin® 44 is a foam for oral use. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jan Marsal | Lument AB | +46709822008 | jan.marsal@med.lu.se |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2022 | Jan 19, 2024 | Prot_SAP_000.pdf |
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Overall diagnostic impression: MRE examinations with Lumentin® 44 will be graded for global quality of the information obtained with special reference to diagnostic purposes, as follows:
|
| Day 1 |
Concentration of plasma potassium levels over time |
| Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) |
| Concentration of Plasma Phosphate | Concentration of plasma phosphate levels over time | Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) |
| Concentration of Serum Ionized Calcium | Concentration of serum ionized calcium levels over time | Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) |
| Bowel Filling Properties: Extension/Duodenum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Extension/Jejunum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Extension/Proximal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Extension/Distal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Extension/Terminal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Distension/Duodenum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Distension/Jejunum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Distension/Proximal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Distension/Distal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Bowel Filling Properties: Distension/Terminal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| MR examination, Day 1 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Visual Evaluation of MRE Images -Artefacts | Artefacts: MRE examinations with Lumentin® 44 will be scored with respect to artefacts based on a 5-graded scale, as follows:
| All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Visual Evaluation of MRE Images -Mucosal Evaluation | Mucosal evaluation: MRE examinations with Lumentin® 44 will be scored with respect to mucosal status based on a 5-graded scale, as follows:
| All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Visual Evaluation of MRE Images -Overall Diagnostic Impression | Overall diagnostic impression: MRE examinations with Lumentin® 44 will be graded for global quality of the information obtained with special reference to diagnostic purposes, as follows:
| All MRE images will be evaluated by one expert radiologist. Only one assessment of each MRE examination will be performed | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Concentration of Plasma Sodium | Concentration of plasma sodium levels over time | Posted | Mean | Standard Deviation | mmol/L | Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) |
|
|
|
| Secondary | Concentration of Plasma Potassium | Concentration of plasma potassium levels over time | Blood samples at various time points could not be analysed due to error in handling of samples. | Posted | Mean | Standard Deviation | mmol/L | Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) |
|
|
|
| Secondary | Concentration of Plasma Phosphate | Concentration of plasma phosphate levels over time | Posted | Mean | Standard Deviation | mmol/L | Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) |
|
|
|
| Secondary | Concentration of Serum Ionized Calcium | Concentration of serum ionized calcium levels over time | Blood samples at various time points could not be analysed due to error in handling of samples. | Posted | Mean | Standard Deviation | mmol/L | Blood samples will be drawn at baseline just before intake of contrast agent (T0h), and then at 1 hour (T1h), 2 hours (T2h), 4 hours (T4h), 6 hours (T6h), 8 hours (T8h) and at 24 hours (T24h) |
|
|
|
| Secondary | Bowel Filling Properties: Extension/Duodenum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Extension/Jejunum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Extension/Proximal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Extension/Distal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Extension/Terminal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Distension/Duodenum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Distension/Jejunum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Distension/Proximal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Distension/Distal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| Secondary | Bowel Filling Properties: Distension/Terminal Ileum | Bowel filling properties: Extension and distension will be evaluated in each of five selected sub-segments of the small bowel. All images will be evaluated by the investigator with respect to how well the small bowel is filled from the bowel through to the terminal ileum (extension) and how well it is distended (distension) by Lumentin® 44. The small bowel will be divided in duodenum, jejunum, proximal ileum, distal ileum and terminal ileum. Both variables will be judged on a scale from 1 to 5, as follows:
| Posted | Count of Participants | Participants | MR examination, Day 1 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
Not provided
Not provided
| Small artefacts, minimal bright edges in the interface between lumen/wall, somewhat better than MRE |
|
| No artefacts and better than conventional MRE |
|
| Small mucosal folds can be discriminated, somewhat better than for conventional MRE |
|
| Mucosal folds are seen in detail and better than conventional MRE |
|
| Very good diagnostic quality, somewhat better than conventional MRE |
|
| Excellent diagnostic quality, better than conventional MRE |
|
| Title |
|---|
| Measurements |
|---|
|
| T4h |
|
| T6h |
|
| T8h |
|
| T24h |
|
|
| T2h |
|
|
| T4h |
|
|
| T6h |
|
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| T8h |
|
|
| T24h |
|
|
| Title |
|---|
| Measurements |
|---|
|
| T4h |
|
| T6h |
|
| T8h |
|
| T24 |
|
|
| T2h |
|
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| T4h |
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| T6h |
|
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| T8h |
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| T24h |
|
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| Title | Measurements |
|---|---|
|
| Extension/duodenum, Score 4 |
|
| Extension/duodenum, Score 5 |
|
| Title | Measurements |
|---|---|
|
| Extension/jejunum, score 4 |
|
| Extension/jejunum, score 5 |
|
| Title | Measurements |
|---|---|
|
| Extension/proximal ileum, score 4 |
|
| Extension/proximal ileum, score 5 |
|
| Title | Measurements |
|---|---|
|
| Extension/Distal ileum, score 4 |
|
| Extension/Distal ileum, score 5 |
|
| Title | Measurements |
|---|---|
|
| Extension/terminal ileum, score 4 |
|
| Extension/terminal ileum, score 5 |
|
| Title | Measurements |
|---|---|
|
| Distension/duodenum, Score 4 |
|
| Distension/duodenum, Score 5 |
|
| Title | Measurements |
|---|---|
|
| Distension/jejunum, Score 4 |
|
| Distension/jejunum, Score 5 |
|
| Title | Measurements |
|---|---|
|
| Distension/proximal ileum, score 4 |
|
| Distension/proximal ileum, score 5 |
|
| Title | Measurements |
|---|---|
|
| Distension/distal ileum, score 4 |
|
| Distension/distal ileum, score 5 |
|
| Title | Measurements |
|---|---|
|
| Distension/terminal ileum, score 4 |
|
| Distension/terminal ileum, score 5 |
|